Vaccines, Blood & Biologics

2018 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 in reverse chronological order.

2018 Biological Device Application Approvals
Tradename/Common NameDescription and Indication for DeviceSubmission IDManufacturerClearance Date

Patient Health Software (P.H.S) Version 2.0

 

Blood Establishment Computer Software and Accessories

The Patient Health Software (PHS) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to: blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. PHS is designed to aid and assist qualified and trained personnel to support the operations within their facilities. PHS software supports single, centralized multi-sites and multi-organizations to be used centrally or in stand-alone.
PHS undertakes process controls for testing laboratory and transfusion service operations on testing on patients, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety.
PHS is intended to address all phases of laboratory activities and/or transfusion services operations at laboratory department, transfusion service departments, hospital wards and patient bed side. Functionality is provided for:
• Patient identification at bed side and patient record management;
• Supporting Patient immunohematology, virology, histocompatibility laboratory testing used for suitability and including reagent quality control;
• Supporting human leukocyte antigen (HLA) laboratory testing for suitability;
• Blood components preparation, release and labeling (ISBT 128);
• Blood components selection, testing and issue of blood components under normal and emergency conditions, including serological crossmatch, electronic crossmatch and remote crossmatch of blood components;
• Tracking of blood components disposition, record transfusion details and related outcome and record keeping of patient transfusion history for lookback.

PHS interfaces with Health Information Systems, laboratory testing instruments, BECS, Laboratory Information Systems (LIS) and blood storage devices.
BK180232/0

MAK-SYSTEM SA International Group

10 Avenue de la Grande-Armee,
Paris, 75017,
France

10/18/2018

ID CORE XT

Molecular erythrocyte typing test

ID CORE XT (Reagents and ANALYSIS SOFTWARE) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding HEAs in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms that predict 53 HEA alleles and 37 antigens of the blood group systems Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright, and Lutheran.BP170154/0

Progenika Biopharma, S.A.

Ibaizabal bidea,
Edificio 504,
Derio, Bizkaia, 48160

Spain
10/11/2018

ID CORE CONTROL

Quality control for molecular immunohematology tests

The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL I and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2) of the 29 polymorphisms interrogated by ID CORE XTTM. Both control vials must be used in every run of the ID CORE XT test.
ID CORE CONTROL samples are not intended to monitor the DNA extraction step of the ID CORE XTTM processing protocol.

BK170092/0

Progenika Biopharma, S.A.

Ibaizabal bidea,
Edificio 504,
Derio, Bizkaia, 48160

Spain
10/11/2018

HemoMix 3 with DCSX Software

Blood Mixing and blood weighing device

HemoMix 3 with optional DCSX Software is an automated blood monitor/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 target volume has been reached.BK180229/0

Delcon S.R.L

Via Zanica,
Grassobbio,
BG, 24050,

ITALY
10/04/2018

VistA Blood Establishment Computer Software (VBECS) Version 2.3.0

Blood Establishment Computer Software and Accessories

VistA Blood Establishment Computer Software (VBECS) is a computer software application that manages transfusion service activities. The purpose of VBECS is to automate the documentation and record keeping of selected daily activities of the transfusion service.

BK180227/0

Department of Veterans Affairs

P.O Box 7008,
5th Ave and Roosevelt Rd,
Hines, IL 60141,

US
10/01/2018
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 and IH-Reader 24 with IH-System reagents or the TANGO infinity® with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with:
  • a standalone or multiple IH-1000 systems,
  • a standalone or multiple IH-Reader 24 systems,
  • a standalone TANGO infinity® or multiple TANGO infinity® systems;
    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”.

BK180226/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
Dreieich, 63303,
GM
9/28/2018
IH-Reader 24
Automated Blood Grouping and Antibody Test Systems
The IH-Reader 24 is an instrument intended for the in vitro serological analysis of human blood specimens for blood grouping and antibody detection. IH-Reader 24 performs centrifugation and provides reaction grading / interpretation based on results from IH-System gel card images. In the USA, IH-Reader 24 is "Rx only".

The IH-Reader 24 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-Reader 24 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. IH-Reader 24 is allowed to use gel cards from the IH-System authorized by Bio-Rad. The use of any material not specified in the User Manual (e.g. non-authorized substances) is under the users' responsibility.

BK180225/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
Dreieich, 63303,
GM
9/28/2018
RECELL® Autologous Cell Harvesting DeviceThe ReCell® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds in patients 18 years of age and older. The RECELL® Device is used by an appropriately-licensed healthcare professional at the patient’s point-of-care to prepare autologous Regenerative Epidermal Suspension(RESTM) for direct application to acute partial-thickness thermal burn wounds or application in combination with meshed autografting for acute full-thickness thermal burn wounds.BP170122/0Avita Medical Americas, LLC
28159 Avenue Stanford,
Suite 220
Valencia, CA, 91355-2271
9/20/2018
MEDITECH Expanse Blood Bank
Blood Establishment Computer Software and Accessories
The MEDITECH Blood Bank Software provides a variety of functionality for healthcare personnel. The software helps personnel, in both multiple and single facility organizations, manage their departments more efficiently by integrating donor, unit, and patient information.

The MEDITECH Blood Bank Software assists with:
  • Tracking of donor products from receipt to final disposition
  • Specimen cross matching
  • Specimen electronic crossmatching
  • Determining the suitability of released products upon issuing
  • Recording of transfusion information
  • Tracking product disposition

The MEDITECH Blood Bank Software interfaces to the following Blood Bank Analyzer for the purposes of specimen resulting and transmitting the results to the MEDITECH Blood Bank Software: Galileo Echo

The software also allows online inquiries and permanent storage of:

  • Donor history
  • Crossmatch results
  • Antigens/Antibodies
  • Transfusion data
  • Unit history
  • Patient's comprehensive blood bank history
BK180219/0Medical Information Technology, Inc.
Meditech Circle
Westwood, MA 02090
9/12/2018
Trima Accel® Automated 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.

Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:

  • Double ACD-A/AS-3 Red Blood Cells (leukocytes reduced or not leukoreduced)

Or the following products alone or in combination:

  • ACD-A/AS-3 Red Blood Cells
  • ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced utilizing an integrated filter (TLR gravity drain filter or Auto RBC filter)
  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (Isoplate) (single, double, or triple units)
  • Plasma

Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. Platelets Pheresis, Leukocyte Reduced, Platelet Additive Solution (Isoplate) (single or double units) may be further processed (e.g., irradiated, divided). Platelets Pheresis, Platelet Additive Solution (Isoplate) (single or double units) may not be manufactured from products that do not meet leukocyte reduction product standards.

The storage conditions of the Trima Platelet bag (ELP bag) have been verified for storage up to 7 days post-collection in 100 % Plasma and up to 5 days in Isoplate Solution (PAS-F). Additionally, for storage up to 7 days, every product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.”

The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.

  • Adequate studies have not been performed to evaluate the effect of gamma irradiation or freezing on the quality of ACD-A/AS-3 red blood cells products (RBCs) collected with gravity drain leukoreduction process (TLR filter) on the Trima Accel system.
  • Studies have not been performed to support gamma irradiation or freezing of ACD-A/AS-3 RBCs collected with an integrated in-line RBC leukoreduction filter(s) (Auto RBC filter) on the Trima Accel system
BK180231/0Terumo BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215
8/17/2018
DXT Data Management System 3.1
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 procedure 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.BK180230/0Fresenius Kabi AG
Three Corporate Dr,
Lake Zurich, IL 60047
8/14/2018
BD BACTEC™ Platelet Aerobic/F Culture vials
BD BACTEC™ Platelet Anaerobic/F Culture Vials

Microbial growth monitor

BD BACTEC™ Platelet Aerobic/F Culture vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Aerobic/F Culture vials support the growth of aerobic microorganisms (bacteria and fungi).

BD BACTEC™ Platelet Anaerobic/F Culture Vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Anaerobic/F Culture Vials support the growth of anaerobic microorganisms.

BK180211/0Becton, Dickinson & Company
7 Loveton Circle, MC 694
Sparks, MD 21152-0999
8/8/2018
Safe Trace Tx 4.0.0
Blood Establishment Computer Software and Accessories

SafeTrace Tx is an electronic information system used by single-site, multi-site and centralized transfusion services to manage the blood transfusion process. It manages and tracks blood product information from receipt to final shipment and disposition.

SafeTrace Tx is an electronic information system that manages the blood transfusion process and assists in the determination of the suitability of released products. It manages and tracks blood product information relating to receipt, reservation, modification, testing, and final shipment and disposition. The application manages and provides a centralized view of patient, visit, and order information, including positive patient identification and patient, testing and transfusion history.

The system can perform electronic crossmatching and safety and compatibility checks between patient and product. Component attributes, such as human leukocyte antigen (HLA) attributes, can be entered into SafeTrace Tx.

SafeTrace Tx can operate stand-alone or interface with:

  • Labeling systems
  • Test lab systems, analyzers, and equipment
  • Hospital information systems
  • Laboratory information systems
  • Blood tracking and/or storage devices
  • Inventory systems (including other Blood Establishment Computer Software (BECS) systems)
BK180209/0Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
8/7/2018
Galileo Echo®
Automated Blood Grouping and Antibody Test Systems
The Galileo Echo® is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo® automates test processing, result interpretation and data management functions. The Galileo Echo® is designed to automate standard immunohematology assays using a micro-well strip-based platform. Assays include ABO and Rh(D) typing, detection/ identification of IgG red blood cell antibodies, compatibility testing and red blood cell phenotyping.

The Galileo Echo® is for in vitro diagnostic use.
BK180220/0Immucor, Inc.
3130 Gateway Drive,
Norcross, GA 30091
7/17/2018
Royal MaxxPRP Concentration System
Platelet And Plasma Separator For Bone Graft Handling
The Royal MaxxPRP Concentration System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.BK180204/0Royal Biologics LLC
190 Columbus Drive, Suite #2A
Jersey City, NJ 07302
7/12/2018
Arthrex Angel System Kit
Platelet and Plasma Separator For Bone Graft Handling
The Arthrex Angel System Kits are to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet rich plasma and platelet rich plasma are mixed with autograft and /or allograft bone prior to application to a bony defect for improving handling characteristics.BK180180/0Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108
7/5/2018
LifeTrak2018
Blood Establishment Computer Software and Accessories
LifeTrak® 2018 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following:
  • Dynamic donor eligibility status
  • Register, track, and audit donations and deferrals
  • On-line health history, physical findings, and collection process
  • Inter-active donor questionnaire (staff and/or donor/remote donor)
  • HLA/RBC search and match
  • Donor Schedules
  • Component production and modification
  • Testing
  • Labeling
  • Imported blood processing
  • Inventory management
  • Distribution
  • Material Check-In
  • Offline Data Entry (Re-entry if downtime)
  • LifeTrak is usable with wired/wireless networks supporting TCP/IP protocols
BK180200/0Mediware Information Systems, Inc.
11711 West 79th
Lenexa, KS 66214
7/3/2018
DonorScreen-HLA® Class I and Class II
Test, HLA
DonorScreen-HLA® Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the STRATEC BIOMEDICAL AG® GEMINI instrument. DonorScreen-HLA® Class I and Class II assay ELISA is designed to detect anit-HLA class I and class II antibodies in human serum or plasma of blood donors.BK180181/0Immucor GTI Diagnostics, Inc.
20925 Crossroads Circle
Waukesha, WI 53186
6/14/2018
RD1 System
Peripheral blood processing device for wound management
The RD1 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot get from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the whole blood clot gel produced by the RD1 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.BK170095/0RedDress Ltd
Shkedim Street 11, Pardes Hanna, Zip 3701142 Israel
6/14/2018
Biowy Freezing Bag
Frozen Donor Tissue Storage Container
The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196 Celsius) and subsequent thawing (at +37 Celsius) of hematopoietic progenitor cells.BK170150/0Biowy Corporation
27031 Vista Terrace
Lake Forest, California 92630
5/11/2018
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System
Platelet And Plasma Separator for Bone Graft Handling
The Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of whole blood or a small mixture of blood and bone marrow. The platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site. The Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed for the preparation of autologous serum from anticoagulated peripheral blood or platelet poor plasma that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics.BK170144/0Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
5/10/2018
TANGO Infinity Software Version 1.5
Automated Blood Grouping and Antibody Test Systems
The TANGO infinity automated blood grouping and antibody test system is an automated instrument intended for the in vitro serological analysis of human blood specimens. In the USA, TANGO is “RX only”and operates with TANGO Infinity Software Version 1.5. It generates results from individual images that must be verified by visual inspection by a qualified person called a validator. In rare cases, where the software is unable to decide, manual editing may be necessary.

TANGO Infinity utilizes Erytpe S agglutination metholodology for ABO (forward and reverse blood grouping), Rh(D), Rh Phenotype and Kell blood grouping.

TANGO infinity utilizes Solidscreen II solidphase methodology for weak D and partial D testing, antibody screening and identification of red cell alloantibodies, auto control and direct antiglobulin testing. The TANGO infinity uses reagents and microwell strips approved for the TANGO infinity.

Operators of TANGO infinity must be trained by authorized personnel and must be familiar with the content of this TANGO infinity User Manual. This TANGO infinity User Manual is designed to serve as a reference manual for operations and troubleshooting, to assist writing institutional SOPs and to assist in training.
BK180175/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
63303 Dreieich, Germany
5/1/2018
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 or the TANGO infinity®; with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data.

IH-Com V5.0 may be used with:
  • a standalone IH-1000, with multiple IH-1000 systems;
  • a standalone TANGO infinity®; or multiple TANGO infinity®; systems; 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”.
BK180174/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
63303 Dreieich, Germany
5/1/2018
PCS 300 Plasma Collection System (Software Version 1.2.0)
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.BK180185/0Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
3/27/2018
Neg Control
Quality Control Kits for Blood Banking Reagents
Neg Control is used as a negative control in conjunction with DIAGAST monoclonal Anti-D reagents (210524-210525-210526).BK160084/0DIAGAST
Parc Eurasanté 251, Avenue Eugéne BP 9, LOOS Cedex,
France 59374
2/2/2018
BacT/ALERT® BPA Culture Bottle
Bacterial Detection Systems for Platelet Transfusion Products

BacT/ALERT® BPA culture bottles are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). BacT/ALERT® BPN culture bottle are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic and facultative anaerobic microorganisms (bacteria).

BacT/ALERT Microbial Detection Systems and culture bottles may be used for quality control testing of platelets and as a secondary safety measure test. Bacterial tests are labeled as safety measure when they show benefit for detection of bacterial contamination not revealed by previous bacterial testing. The laboratory should follow its own quality control procedures for these uses.

BK170142/0BioMerieux, Inc.
595 Anglum Road
Hazelwood, MO 63042
2/1/2018
EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid)
Fibrin Sealant Preparation Device
The EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) is intended to be used with the EVICEL™ Application Device for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant (Human) onto the surface.BK170138/0ETHICON Inc.
Route 22 West
Somerville, New Jersey 08876
1/26/2018
UltraCW®II Automatic Cell Washing System
Automated cell-washing centrifuge for immune-hematology

The UltraCW®II Automatic Cell Washing System is intended to be used for the washing portion of routine blood bank and laboratory procedures calling for washed red blood cells such as antiglobulin testing, ABO compatibility, Rh, cross matching and anti-body screening.

The UltraCW®II Automatic Cell Washing System should be operated by a trained individual such as a clinical laboratory technologist or similar education as determining whether desired results have been achieved is subjective and is dependent upon user preparation of blood sample, and parameter selection/adjustment.

BK170141/0Helmer Inc.
14400 Bergen Boulevard
Nobelsville, IN 46060
1/22/2018
Procleix Xpress® System (Software v3.0)
Automated blood grouping and antibody test system
The Procleix Xpress® System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress® System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix® systems. The Procleix Xpress® System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress® System can be used to dispense human plasma or serum aliquots into an archive plate.BK170162/0Grifols Diagnostic Solutions Inc.
4560 Horton Street
Emeryville, CA 94608
1/18/2018
Cyclone Blood & Bone Marrow Concentration (BBMC) System
Platelet And Plasma Separator For Bone Graft Handling
The Cyclone Blood BBMC System is designed to be used intraoperatively at the point of care for the safe and rapid preparation of a platelet concentrate (platelet rich plasma or PRP) from a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improved handling characteristics.BK170108/0Alliance Partners LLC
14206 Northbrook Drive
San Antonio, TX 78232
1/2/2018

 

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