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

GUDID

Device Identifier (DI) Information

Brand Name: Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System
Version or Model: GSD01-1600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B350GSD0116000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51819	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GMQ	Antigens, Nontreponemal, All

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bbf37193-67f5-406b-89d3-3caa92dd4d87
Public Version Date: June 04, 2021
Public Version Number: 3
DI Record Publish Date: September 27, 2016