DEVICE: Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System (B350GSD0116000)

Device Identifier (DI) Information

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System
GSD01-1600
In Commercial Distribution

GOLD STANDARD DIAGNOSTICS CORP.
B350GSD0116000
HIBCC

1
790524891 *Terms of Use
Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No
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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
Treponema pallidum reagin antibody IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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FDA Product Code

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Product Code Product Code Name
GMQ Antigens, Nontreponemal, All
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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

bbf37193-67f5-406b-89d3-3caa92dd4d87
March 29, 2018
2
September 27, 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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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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