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  1. Vaccines, Blood & Biologics

2017 Biological Device Application Approvals

2017 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.

2017 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date

ASI RPR Test for Syphilis for Use on the ASI Evolution

Treponema pallidum nontreponemal test reagents
The ASI Automated RPR (rapid plasma reagin) Test for syphilis is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis for use on the ASI Evolution analyzer. The ASI RPR Test for Syphilis is for professional use only. The test is intended for use in screening blood donors. BK170114/0

Arlington Scientific, Inc.
1840 North Technology Drive
Springville, UT84663

12/28/2017

IH-Basic QC

Quality Control Kits for Blood Banking Reagents

The IH-Basic QC is intended for daily quality control of blood bank reagents including Blood Grouping Reagents for ABO/Rh, Rh Phenotyping, K, Reagent Red Blood Cells and reagents for antibody detection.

The IH-Basic QC is "Rx Only".  For use with IH-Card Technique using the IH-1000 Analyzer.

BK170075/0 Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1, Dreieich,  GM 63303
12/20/2017

TS Meter-DSP

Refractor for Donor testing

The TS Meter-DSP is for the qualitative measurement of total protein in human serum/plasma. The device is intended for use in plasma collection centers and is not for diagnostic purposes. BK 170128/0 Reichert, Inc. 3362 Walden Avenue, Suite 100
Depew, NY 14043
12/19/2017

IH-Centrifuge L

 Manual blood grouping and antibody  systems

The IH-Centrifuge L is intended for cetrifugation of IH-System gel cards and/or test tubes for in vitro immunohematology testing of human blood. In the USA, IH-Centrifuge L is “Rx only.”

The IH-Centrifuge L may only be operated by trained personnel and is not intended for use in a direct patient environment.

Use of the IH-Centrifuge L is only permitted in conjuction with the corresponding software or in a configuration authorized by Bio-Rad.

The use of any material not specified in the User Manual (e.g. non-authorized substances) is under users responsibility.

BK170065/0 Bio-Rad Medical Diagnostics GmbH Industriestrasse 1, Dreieich, GM 63303 12/18/2017

IH-Incubator  L

Manual blood grouping and antibody systems

The IH-Incubator L is intended for cetrifugation of IH-System gel cards and/or test tubes for in vitro immunohematology testing of human blood. In the USA, IH-Incubator L is “Rx only.”

The IH-Incubator L may only be operated by trained personnel and is not intended for use in a direct patient environment.

Use of the IH-Incubator L is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad.
The use of any material not specified in the User Manual (e.g. non-authorized substances) is under users’ responsibility.

Prescription
BK170066/0

Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1, Dreieich, GM 63303

12/18/2017

IH-Internal QC

 Quality Control Kits for Blood Banking Reagents

The IH-Internal QC is intended for blood grouping controls including antisera for ABO/Rh, Rh Phenotyping, K, Reagent Red Blood Cells and reagents for antibody detection and identification.

The IH-Internal QC is designed to be used with IH-Cards only with the manual method. The IH-Internal QC is “Rx only.”

BK170064/0

Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1, Dreieich, GM 63303

12/18/2017

myPKFiT for ADVATE Version 2.0

sparse sample pk profile and dosing software

The myPKFiT for ADVATE software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. myPKFiT for ADVATE can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient. A minimum of two sparse sampling points are required at the recommended 3-4 hours (±30 minutes) and at 24-32 hours (±1 hour) post-infusion.

HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient’s needs and treatment plan. The medical device output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with FDA approved dosing recommendations provided in the ADVATE Prescribing Information (PI).

myPKFiT for ADVATE should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE PI. myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. myPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

BK170028/0

Baxalta US Inc.
One Baxter Way, Westlake Village, CA, 91362,

12/14/2017

VITROS Immunodiagnostic Products HIV Combo Reagent Pack

VITROS Immunodiagnostic Products HIV Combo Calibrator

HIV-1/2 Ag/Ab Test

VITROS Immunodiagnostic Products HIV Combo Reagent Pack is for the simultaneous qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum and plasma (heparin and EDTA) in adults, pregnant women, adolescents and children (as young as 2 years of age), using the VITROS 3600 Immunodiagnostic System.

The VITROS HIV Combo Calibrator is for use in the calibration of the VITROS 3600 Immunodiagnostic System.

BP160122/0 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive, Rochester, NY, 14626, US
12/13/2017

Samplok ®Segment Sampler

Blood Bank Supplies
To aid in the extraction of a biological fluid sample from a segmented piece of tubing. Single use only. For in vitro diagnostic use only. BK170102/0

ITL Corporation Pty, Ltd

41-45 Tennant Street, Canberra ACT 2609, AS
11/28/2017

Fibrinet®Platelet System

Platelet And Plasma Separator For Bone Graft Handling

The Cascade Medical FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

BK170096/0

Cascade Medical Enterprises, LLC

20 Greenup Court, Wayne, NJ, 07470, US
11/21/2017

MacoPress Smart (MPS) and DMS Plus

Blood Bank Supplies

The MacoPress Smart (MPS) and DMS Plus consist of two parts: the MacoPress Smart device and the DMS Plus Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS Plus software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.

BK170085/0

MacoProductions S.A.S.
200 chaussee Fernand Forest,  Tourcoing,  FR 59200

 

11/9/2017

Erytra®  

Automated Blood Grouping and Antibody Test Systems

The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra® automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing.

BK170130/0

Diagnostic Grifols, S. A.
Passeig Fluvial, 24
Parets Del Valles
Barcelona Spain 08150

11/1/2017
Aurora Enterprise
Blood Establishment Computer Software and Accessories
Aurora Enterprise is a computer software product for use within Blood Establishments and Clinical Diagnostic Laboratories which enables communication between Laboratory Information Systems and Laboratory Instrumentation. The software product is designed to capture and collate data provided by laboratory instrumentation, where the instrumentation is capable of performing its own data processing, having qualified the data and converted the raw values into interpreted results. The software collects data of assays from instruments, which allow operators to track patient samples and link them to the appropriate test results. The software collates the results of testing, and formats output files that can be sent to a Laboratory Information System (LIS). Typical tests would include those that are used to screen blood donations (whole blood or plasma) as a pre-requisite to transfusion such as viral markers tested by NAT/PCRand Immunoassay. The software has the capability to send worklists to instruments from orders it receives from an LIS, or manually entered, but takes no control over any instrument operation. BK160071/0 STRATEC Biomedical UK Limited
Third Ave, Centrum 100, Straffordshire, UK
 
10/30/2017
AlbaQ-Chek Simulated Whole Blood Controls
Quality Control Kits for Blood Banking Reagents
AlbaQ-Check is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. BK170086/0 Alba Bioscience Limited
21 Ellen's Glen Rd,
Edinburgh EH17 7QT Scotland
10/20/2017
ORTHO CONNECT
Automated Blood Grouping and Antibody Test System
ORTHO CONNECTTM Software is designed to collect data from the Ortho Clinical Diagnostics ORTHO VISIONTM Analyzer and its proprietary immunology/hematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation. BK160124/0 STRATEC Biomedical UK Limited
98 Main St. Suite 205
Southington, CT, 06489
10/17/2017
AMICUS Separator System
Automated Blood Cell Separators
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE), and to collect blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. BK170099/0 Fresenius Kabi USA LLC.
Three Corporate
Drive, Lake Zurich, IL,
60047
10/10/2017
Charter Medical Cell Therapy Fluid Transfer Set
Transfer Sets
For the sterile transfer of bone marrow derived mononuclear cells from one container to another. The fluid transfer sets are provided sterile (fluid path) by gamma irradiation and are intended for single use. BK170004/0 Charter Medical, Ltd.
3948-A Westpoint
Blvd. Winston-Salem,
NC, 27103
10/6/2017
One Lambda LABTypeTM XR and CWD DNA Typing Tests
Qualitative Test for HLA, Non-diagnostic
For use to determine HLA A, B, C and DRB1 locus typing to aid in transfusion and transplantation donor recipient matching. BK170053/0 One Lambda, Inc.
21001 Kittridge St.
Canoga Park, CA,
91303
10/5/2017
TSCD®-II Sterile Tubing Welder with or without Trucise Total System™
Transfer Sets
The Terumo Sterile Connecting Device (TSCD®-II) is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components. These welds may consist of dry-to-dry, wet-to-dry or wet-to-wet connections. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. BK170098/0 Terumo BCT, Inc
10811 W. Collins Ave.,
Lakewood, CO, 80215
9/29/2017
DXT Data Management System v3.0
Automated Blood Cell Separators
DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems. The system can be used for electronic record documentation and remote procedures setup to pre-populate procedure parameters on the appropriate instrument. The information available in the system or provided to BECS or other data management systems can be used for medical decision making such as donor deferral/eligibility decisions. DXT can be deployed with apheresis instruments only as stand-alone or as a middleware application to communicate with an existing external system, e.g., BECS and/or data management systems and an apheresis device. BK170072/0 Fresenius Kabi AG
Three Corporate Dr,
Lake Zurich, IL, 60047
9/26/2017
IH-Com V5.0
Automated Blood Grouping and Antibody
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for the blood samples that are tested on the IH-1000 with IH-System reagents. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with a standalone IH-1000, with multiple IH-1000s, or connected to a Laboratory Information System. The user can access selected functions of IH-Com V5.0 from remote locations using IH-Web 2.0. IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-ComV5.0 is “Rx only”. BK170071/0 Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
Dreieich, GM
9/26/2017

Aurora Xi Plasmapheresis System/Aurora Xi/Aurora Xi system/Aurora Xi Software Version 1.1
Automated Blood Cell Separators

The Aurora Xi Plasmapheresis system is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi system is to be used with a single-use PLASMACELL Xi disposable set and 4% sodium citrate anticoagulant, and allows for Saline and No Saline Protocol Options. BK170057/0 Fresenius Kabi AG
Three Corporate Dr,
Lake Zurich, IL,
60047
 
8/25/2017
MacoMix HM20 and Hemolog 6
Blood Mixing and Weighing Devices
The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the preset target volume has been reached. BK160095/0 MacoProductions S.A.S.
200 chaussee
Fernand Forest,
Tourcoing, 59200,
FR
8/11/2017
Haemonetics PCS 300 Plasma Collection System
Automated Blood Cell Separators
The PCS 300 Plasma Collection System is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the PCS 300 system include source plasma and plasma for transfusion. BK170045/0 Haemonetics Corporation
400 Wood Road, Braintree, MA 02184
7/25/2017
Duploject,Duo Set and Duo Set A
Piston Syringe
Duploject: For the preparation and application of Tisseel Fibrin Sealant kit. Duo Set: For the application of Tisseel Fibrin Sealant. Duo Set A: For the application of Artiss Fibrin Sealant. Prescription BK170033/0 Baxter Healthcare Corporation
32650 North Wilson Rd,
Round Lake, IL 60073
07/24/2017
Bone Marrow Collection Stand
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters
Bone Marrow Collection Kit and Accessories
The Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow for bone marrow transplantation. BK170030/0 Fresenius Kabi AG
Three Corporate Drive,
Lake Zurich, IL 60047
07/24/2017
Galileo Neo®
Automated Blood Grouping and Antibody Test Systems
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate- based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can be subjected to confirmation using a licensed method. The NEO is intended for use only with the reagents described in Attachment 1 for Galileo Neo Operator Manual. BK170067/0 Immucor, Inc.
3130 Gateway Drive,
P.O.Box 5625 Norcross, GA 30091
7/19/2017
Trima Accel (R) Blood Collection System
Automated Blood Cell Separators
The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients. BK170059/0 Terumo BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215
7/7/2017
Blood Product Administration Module, Version 2-2017
Blood Establishment Computer Software and Accessories
The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion. The Module is based on a modular design allowing it to be used with a host electronic health record system. The Module can, through use of barcode technology, assist healthcare professionals in verifying patient identity at the bedside. The Module receives and manages information from orders placed from host system and blood product information from an external blood bank system. The Module incorporates system-controlled logic that can require a positive match of the patient, the blood product to be administered, and information received from the external blood bank system. The Module can also check a blood product's documented expiration date for appropriateness. Blood administration information entered in the Module is transmitted to the host system for storage. BK170032/0 Epic Systems Corporation
1979 Milky Way,
Verona, WI, 53593
06/28/2017
Elecsys HIV combi PT
HIV Detection Test
The Elecsys HIV combi PT is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women. The Elecsys® HIV combi PT Immunoassay is not intended for the screening of blood or plasma donors. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 602 immunoassay analyzer. BP160050/0 Roche Diagnostics 9115 Hague Road,
Indianpolis, IN, 46250
06/21/2017
AlbaQ-Chek ® Simulated Whole Blood Controls, Model Z498
Quality Control Kits for Blood Banking Reagents
Intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. BK170013/0 Alba Bioscience Limited
21 Ellen's Glen Rd, Edinburgh,
Midlothian, EH17 7QT United Kingdom
05/9/2017
IH-1000 (Model# 001100)
Automated Blood Grouping and Antibody Test Systems
The IH-1000 is designed for Blood Grouping Determination using the IH-Cards, utilizing hemagglutination and gel filtration as principle of operation. The instrument is intended to perform the detection of ABO, RhD (including weak D and partial D testing), Rh and Kell blood grouping for patient and donor samples as well as detection and identification of clinical relevant antibodies, cross matching and Direct Antiglobulin testing using the IH System reagents. BK170019/0 Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
Dreieich, 63303, GM
05/5/2017
IH-Com V5.0
Automated Blood Grouping and Antibody Test Systems

IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000 with IH -System reagents. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with a standalone IH-1000, with multiple IH-1000s, or connected to a Laboratory Information System.

IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-Com V5.0 is “Rx only”.

BK170021/0 Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
Dreieich, 63303, GM
05/5/2017
Procleix® NAT Manager® v1.2 Software
Instrumentation for Clinical Multiplex Text Systems
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports. Procleix NAT Manager Software is intended to be used by Blood Establishment personnel who are trained in its operation and familiar with the associated assays and instruments. BK160125/0 STRATEC Biomedical UK Limited
Third Ave, Centrum 100,
Straffordshire, UK
4/25/2017
cobas Synergy Software (Version 1.0) /Data acquisition software cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas? 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments. BK160113/0 STRATEC Biomedical UK Limited
98 Main Street, Southington, CT, 06489
4/19/2017
AMICUS Separator System
Automated Blood Cell Separators
The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). BK160112/0 Fresenius Kabi USA LLC.
Three Corporate Drive,
Lake Zurich, IL, 60047
4/7/2017
Platelet PGD® Test System
Microbial Growth Monitor
The Platelet PGD Test is a rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in
  • leukocyte reduced apheresis platelets (LRAP) suspended in plasma, LRAP suspended in Platelet Additive Solution C (PAS-C) and plasma, and pre-storage pools of up to six (6) leukocyte reduced whole blood derived platelets suspended in plasma, within 24 hours prior to platelet transfusion as a safety measure following testing with a growth-based quality control test cleared by FDA for platelet components
  • post-storage pools (pooled within four (4) hours of transfusion of up to six (6) units of leukocyte reduced (LR) and non-leukocyte reduced (nLR) whole blood derived platelets (WBDP) suspended in plasma and
  • single units of LR and nLR WBDP suspended in plasma and tested within four (4) hours prior to platelet transfusion as individual platelet units or as components of a post-storage pool
BK160087/0 Verax Biomedical Incorporated
148 Bartlett Street,
Marlborough, MA, 01752
4/6/2017
3C Patch System
Peripheral blood processing device for wound management
The 3C Patch System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds. BK170002/0 Reapplix Aps
Blokken 45,
3460 BirkerØd Denmark
4/3/2017
Alyx Component Collection System
Automated Blood Cell Separators
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components. BK170001/0 Fenwal Inc
Three Corporate Dr,
Lake Zurich, IL, 60047
04/3/2017
MQC-CAT
Quality Control Kits for Blood Banking Reagents
MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techniques and for the quality control of certain antigen typing reagents including C, c, E, and e antigents. BK160081/0 Hemo bioscience, Inc.
633 Davis Drive,
Morrisville, NC, 27560
03/30/2017
HLA Fusion™ Software Version 4.0
Qualitative Test for HLA, Non-diagnostic
HLA Fusion™ Software is an accessory for the evaluation of test results from One Lambda, Inc. products for molecular typing and antibody detection. BK160017/0 One Lambda, Inc.
21001 Kittridge St.,
Canoga Park, CA, 91303
3/8/2017
LABType™ XR and CWD DNA Typing Test
Qualitative Test for HLA, Non-diagnostic
To determine HLA A, B, DRB1 locus typing to aid in transfusion and transplantation donor recipient matching. BK160018/0 One Lambda, Inc.
21001 Kittridge St.,
Canoga Park, CA, 91303
3/6/2017
MQC
Quality Control Kits for Blood Banking Reagents
MQC is intended for the quality control of routine blood bank reagents and for the quality control of certain antigen typing reagents including C, c, E,e, Jka, Jkb,K, Fya and Fyb antigents. BK160079/0 Hemo bioscience
633 Davis Drive,
Morrisville, NC, 27560
02/27/2017
cobas® HIV-1
HIV Detection Test
Cobas HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1 infected individuals using the automated cobas 6800/8800 specimen processing, amplification and detection systems. This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment. The cobas HIV-1 test is not intended for use as a screening test for the presence of HIV-1 infection. BP150262/6 Roche Molecular Systems, Inc.
4300 Hacienda Drive,
Pleasanton, CA, 94588
02/10/2017