DEVICE: Anti-B (Murine Monoclonal) Series 3 (10888234001997)
Device Identifier (DI) Information
Anti-B (Murine Monoclonal) Series 3
0006407
In Commercial Distribution
0006407
IMMUCOR, INC.
0006407
In Commercial Distribution
0006407
IMMUCOR, INC.
Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
52538 | Anti-B red blood cell grouping IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for group B [ABO002] red blood cell antigens, using an agglutination method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 1 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
29ca35ba-aa89-4da7-8a0a-e8ff6613bf22
March 29, 2018
2
April 14, 2016
March 29, 2018
2
April 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-855-466-8267
tech_support@immucor.com
tech_support@immucor.com