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August 14, 2008 Approval Letter - Erytype S

August 14, 2008

Our STNS: Please see below.

Biotest Medical Diagnostics GmbH
Attention: Dr. Rolf Vornhagen
Industriestrasse 1
D-63303 Dreieich
GERMANY

Dear Dr. Vornhagen:

We have approved your biologics license applications for the Blood Grouping Reagents listed below effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, these Blood Grouping Reagents under your existing Department of Health and Human Services U.S. License No. 1798. These Blood Grouping Reagents are for use on the Erytype® S Rh + K Type plate for Rh and Kell typing on the TANGO® optimo automated blood grouping and antibody test system.

 

Our STN

Product Proper Name
(Blood Grouping Reagent)

Cell Line(s)

Fill Volume

Dating Period

Date of Manufacture (DOM)

BL 125202/0

Anti-E (Monoclonal)
(Formulated for Automated Testing)

MS260
MS12

---------
dried on microwell strip

18 months

Date of filling into microwells

BL 125203/0

Anti-e (Monoclonal)
(Formulated for Automated Testing)

MS16
MS21
MS63

-----------
dried on microwell strip

18 months

Date of filling into microwells

BL 125204/0

Anti-K (Monoclonal)
(Formulated for Automated Testing)

MS56

---------
dried on microwell strip

18 months

Date of filling into microwells

BL 125205/0

Anti-c (Monoclonal)
(Formulated for Automated Testing)

MS33

---------
dried on microwell strip

18 months

Date of filling into microwells

BL 125206/0

Anti-C (Monoclonal)
(Formulated for Automated Testing)

MS24
P3x25513G8

---------
dried on microwell strip

18 months

Date of filling into microwells

BL 125218/0

Anti-D
(Monoclonal)(IgG Blend)
(Formulated for Automated Testing)

BS221
H4111B7

5 ml(liquid)

24 months

Date of ------- ----------

 

Under this authorization, you are approved to manufacture these Blood Grouping Reagents at your facility in Dreieich, Germany. You may label your Blood Grouping Reagent products with the proprietary name Erytype® S and market them in the fill volumes indicated above.

The dating periods for these Blood Grouping Reagents shall be 18 or 24 months, as listed above, from the date of manufacture when stored at 2-8oC. The dates of manufacture are defined in the table above. ---------------------------
--------------------------------------------------------------------------------------------------------------------

Please submit samples of each of these products in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).

You must submit information to your biologics license applications for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of these products, or in the manufacturing facilities.

We acknowledge your commitment to provide summaries of your shipping validation study(ies) and your stability studies as soon as the data are available.

Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80 (k)(2). Since your products are characterized as devices as well as biologicals, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, Maryland 20847-3002.

You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by FDA Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and had them approved.

Sincerely yours,

/Jay S. Epstein, MD/

Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448