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Categorical Exclusion under 21 CFR 25.31(c) - Seraclone Blood Grouping Reagent Anti-S (Monoclonal)

To:   Administrative Bundled File Biotest AG (LIC #1702):

Products for use on the Tango Automated Blood Group Analyzer 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 125218/0Blood 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 125223/0

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 125242/0Anti-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 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

____________________________________________
DateMarion Michaelis
Committee Facility/CMC Reviewer

Concurrence:

____________________________________________
DateJohn A. Eltermann, Jr., R.Ph., M.S.
Director
Division of Manufacturing and Product Quality

 


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