DEVICE: Lymphoscreen ABC-60 (07611969952939)

Device Identifier (DI) Information

Lymphoscreen ABC-60
823300
Not in Commercial Distribution
823300
Bio-Rad Medical Diagnostics GmbH
07611969952939
GS1
March 08, 2018
1
312576506 *Terms of Use
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC) A collection of reagents and other associated materials intended to be used for the identification in a clinical specimen of one or multiple antibodies to HLA class I antigens, using lymphocyte antigens together with a complement-dependent cytotoxicity (CDC) method.
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FDA Product Code

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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

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Storage and Handling
Storage Environment Temperature: less than -70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8399256a-671a-4b2a-b481-fbcb4476b9ce
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

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

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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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