DEVICE: Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit (B350GSD0610180)

Device Identifier (DI) Information

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit
GSD06-1018
Not in Commercial Distribution

GOLD STANDARD DIAGNOSTICS CORP.
B350GSD0610180
HIBCC
June 12, 2017
1
790524891 *Terms of Use
Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk
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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
Borrelia burgdorferi total antibody IVD, kit, immunoblot A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
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FDA Product Code

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Product Code Product Code Name
LSR Reagent, Borrelia Serological Reagent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 Record Status

6da604a2-f23c-481a-b7a6-3dda386cf155
March 29, 2018
2
September 26, 2016
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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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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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