DEVICE: Control-HLA (pos.) (07611969953172)

Device Identifier (DI) Information

Control-HLA (pos.)
824101
In Commercial Distribution
824101
Bio-Rad Medical Diagnostics GmbH
07611969953172
GS1

1
312576506 *Terms of Use
For use in the microlymphocytotoxicity test
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
HLA class I & II antigen tissue typing IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
MZI Test,Qualitative,For Hla,Non-Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

be2fbedd-1888-4b79-b633-0b833269f936
March 29, 2018
2
July 01, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-224-6723
techsupport.bmd@bio-rad.com
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