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Review Memo: Categorical Exclusion Under 21CFR 25.31(c) - Seraclone Anti-s (Monoclonal)

Food and Drug Administration
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 SystemsCell 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 125218/0Blood 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 125223/0Blood Grouping Reagent, Anti-D (Monoclonal Blend)
BS232/BS221/H4111B7
BL 125226/0Blood Grouping Reagent, Anti-C (Monoclonal)
MS24
BL 125227/0Blood Grouping Reagent, Anti-c (Monoclonal)
MS33
BL 125228/0Blood Grouping Reagent, Anti-E (Monoclonal)
MS12/MS260
BL 125229/0Blood Grouping Reagent, Anti-e (Monoclonal)
MS16/MS21/MS63
BL 125212/0Blood Grouping Reagent, Anti-Fy a (Monoclonal)
GD-FYA-02
BL 125214/0Blood Grouping Reagent, Anti-s (Monoclonal)
P3YAN3
BL 125216/0Blood Grouping Reagent, Anti-S (Monoclonal)
MS94
BL 125217/0Blood Grouping Reagent, Anti-Jk b (Monoclonal)
MS8
BL 125231/0Blood Grouping Reagent, Anti-Jk a (Monoclonal)
MS15
BL 125219/0Blood Grouping Reagent, Anti-A (Murine Monoclonal)
A003
BL 125220/0Blood Grouping Reagent, Anti-B (Murine Monoclonal)
B005
BL 125221/0Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
BS63 and BS85
BL 125224/0Blood Grouping Reagent, Anti-M (Murine Monoclonal)
BS57
BL 125225/0Blood Grouping Reagent, Anti-N (Murine Monoclonal)
BS41
BL 125230/0Blood Grouping Reagent, Anti-K (Monoclonal)
MS56
BL 125232/0Blood Grouping Reagent, Anti-k (Murine Monoclonal)
Lk1
BL 125233/0Blood Grouping Reagent, Anti-Le a (Murine Monoclonal)
LEA2
BL 125213/0Blood Grouping Reagent, Anti- P 1 (Murine Monoclonal)
650

 

Other Reagents for Manual Tubes Testing

 

 (STN) Anti-Human Globulin Cell Line(s)
 BL 125242/0Anti-Human Globulin (Rabbit/Murine Monoclonal)
BRIC-8
 BL 125215/0Anti-Human Globulin
N/A
BL125098/8 Anti-Human Globulin (Formulated for Automated Testing)
N/A
(STN) Reagent Red Blood Cells
Cell Line(s)
BL 125207/0Biotestcell 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 Applications (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 products 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___________________________________________________________   
DateMarion Michaelis    
 Committee Facility/CMC Reviewer  
       
    

 

Concurrence :

 

_____________________________________________________________   
DateJohn A. Eltermann, Jr., R.Ph., M.S.    
 Director,  
 Division of Manufacturing and Product Quality, HFM-670

 

 

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