Product Approval Information
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality
| To: | Administrative Bundled File, Biotest AG (LIC #1702): |
| Products for use on the Tango Automated Blood Group Analyzer |
| (STN) | Biological Products | Cell Line(s) | Strip Proprietary Name |
|---|---|---|---|
|
BL 125097/10 |
Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) |
BS226 |
Component of
Erytype S Rh+K |
| Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) |
BS232 |
Component of Erytype S Rh+K |
|
| BL 125206/0 | Blood Grouping Reagent, Anti-C (Monoclonal) (Formulated for Automated Testing) |
MS24/P3x25513G8
|
Component of Erytype S Rh+K |
| BL 125202/0 | Blood Grouping Reagent, Anti-E (Monoclonal) (Formulated for Automated Testing) |
MS260/MS12
|
Component of Erytype S Rh+K |
| BL 125205/0 | Blood Grouping Reagent, Anti-c (Monoclonal) (Formulated for Automated Testing) |
MS33
|
Component of Erytype S Rh+K |
| BL 125203/0 | Blood Grouping Reagent, Anti-e (Monoclonal) (Formulated for Automated Testing) |
MS16/MS21/ MS63
|
Component of Erytype S Rh+K |
| BL 125204/0 | Blood Grouping Reagent, Anti-K (Monoclonal) (Formulated for Automated Testing) |
MS56
|
Component of Erytype S Rh+K |
NOTE- Erytype S are strip wells (eight wells per strip) containing: Anti-D, Anti-D, Anti-C, Anti-c, Anti-E, Anti-e and Anti-K+ Neg Cont
BL 125208/0 |
Reagent Red Blood Cells For Use in Automated Systems | Cell Line(s) |
|---|---|---|
| Erytypecell A 1 and B | N/A |
|
| Biotestcell Pool; Biotestcell 1, 2; Biotestcell 3 | N/A |
|
Biotestcell I8; Biotestcell I11 |
N/A
|
|
| BL 125218/0 | Blood Grouping Reagent Anti-D (Monoclonal) (IgG Blend) | BS221/H4111B7 |
Seraclone- Liquid BGR for manual tube testing :
| (STN) | Biological Products | Cell Line(s) |
|---|---|---|
| BL 125222/0 | Blood Grouping Reagent, Anti-D (Monoclonal) (IgM) | BS226 |
| BL 125223/0 | Blood Grouping Reagent, Anti-D (Monoclonal Blend) | BS232/BS221/H4111B7 |
| BL 125226/0 | Blood Grouping Reagent, Anti-C (Monoclonal) | MS24 |
| BL 125227/0 | Blood Grouping Reagent, Anti-c (Monoclonal) | MS33 |
| BL 125228/0 | Blood Grouping Reagent, Anti-E (Monoclonal) | MS12/MS260 |
| BL 125229/0 | Blood Grouping Reagent, Anti-e (Monoclonal) |
MS16/MS21/MS63 |
| BL 125212/0 | Blood Grouping Reagent, Anti-Fy a (Monoclonal) | GD-FYA-02 |
| BL 125214/0 | Blood Grouping Reagent, Anti-s (Monoclonal) |
P3YAN3 |
| BL 125216/0 | Blood Grouping Reagent, Anti-S (Monoclonal) |
MS94 |
| BL 125217/0 | Blood Grouping Reagent, Anti-Jk b (Monoclonal) | MS8 |
| BL 125231/0 | Blood Grouping Reagent, Anti-Jk a (Monoclonal) | MS15 |
| BL 125219/0 | Blood Grouping Reagent, Anti-A (Murine Monoclonal) | A003 |
| BL 125220/0 | Blood Grouping Reagent, Anti-B (Murine Monoclonal) | B005 |
| BL 125221/0 | Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) | BS63 and BS85 |
| BL 125224/0 | Blood Grouping Reagent, Anti-M (Murine Monoclonal) | BS57 |
| BL 125225/0 | Blood Grouping Reagent, Anti-N (Murine Monoclonal) | BS41 |
| BL 125230/0 | Blood Grouping Reagent, Anti-K (Monoclonal) | MS56 |
| BL 125232/0 | Blood Grouping Reagent, Anti-k (Murine Monoclonal) | Lk1 |
| BL 125233/0 | Blood Grouping Reagent, Anti-Le a (Murine Monoclonal) | LEA2 |
| BL 125213/0 | Blood Grouping Reagent, Anti- P 1 (Murine Monoclonal) | 650 |
Other Reagents for Manual Tubes Testing
| (STN) | Anti-Human Globulin | Cell Line(s) | |
|---|---|---|---|
| BL 125242/0 | Anti-Human Globulin (Rabbit/Murine Monoclonal) | BRIC-8 |
|
| BL 125215/0 | Anti-Human Globulin | N/A |
|
| BL125098/8 | Anti-Human Globulin (Formulated for Automated Testing) | N/A |
|
| (STN) | Reagent Red Blood Cells | Cell Line(s) |
|
| BL 125207/0 | Biotestcell A 1 and B | N/A |
|
| Biotestcell A 2 | N/A |
||
| Biotestcell Pool; Biotestcell 1, 2; Biotestcell 3 | N/A |
||
| Biotestcell I8; Biotestcell I11 | N/A |
||
| From: | Marion Michaelis HFM-676 |
| Subject: | Categorical Exclusion under 21 CFR 25.31(c) |
| Date: | July 30, 2008 |
|
I have reviewed pertinent sections of the Biologics License Application’s (STN) from Biotest AG (License #1702), for manufacturing multiple new Blood Grouping Reagents, Anti-Human Globulin, and Reagent Red Blood Cells (specified above), and find that the request for a categorical exclusion from an environmental assessment under 21 CFR 25.31(c) is justified because the above mentioned product’s fall into the category of substances that occur naturally in the environment and action would not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
| __07/30/08___ | ________________________________________________________ | ||
| Date | Marion Michaelis | ||
| Committee Facility/CMC Reviewer | |||
Concurrence :
| _____ | ________________________________________________________ | ||
| Date | John A. Eltermann, Jr., R.Ph., M.S. | ||
| Director, | |||
| Division of Manufacturing and Product Quality, HFM-670 | |||