DEVICE: HLA-B SSP Kit (07611969953264)

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Device Identifier (DI) Information

HLA-B SSP Kit
826206
826206
Bio-Rad Medical Diagnostics GmbH
07611969953264
GS1
1
for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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 antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class I antigens in a clinical specimen, using a nucleic acid technique (NAT).
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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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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: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
July 01, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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