Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C GSD01-1600-5C

GUDID B350GSD0116005C0

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

Gold Standard Diagnostics Corporation

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device IDB350GSD0116005C0
NIH Device Record Key701a22cf-0bb7-46a2-9755-06e970eff1b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C
Version Model NumberGSD01-1600-5C
Catalog NumberGSD01-1600-5C
Company DUNS790524891
Company NameGold Standard Diagnostics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB350GSD0116005C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMQAntigens, Nontreponemal, All

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-16
Device Publish Date2024-12-06

Devices Manufactured by Gold Standard Diagnostics Corporation

B350GSD0116005C0 - Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C2024-12-16Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C
B350GSD0116005C0 - Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C2024-12-16 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C
B350GSD051600MW0 - Microtiterplates (5)2024-10-30 Microtiterplates (5)
B35000300CLR0 - ThunderBolt EIA (CLIA)2023-11-08 ThunderBolt EIA-CLIA (refurbished)
B35000300R0 - ThunderBolt EIA2023-11-08 ThunderBolt EIA (refurbished)
B35000400R0 - AIX1000 Analyzer2023-11-08 AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)
B35000500CLR0 - Bolt (CLIA)2023-11-08 Bolt EIA-CLIA (refurbished)
B35000500R0 - Bolt2023-11-08 Bolt EIA (refurbished)
B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit2023-09-21 AIX1000 Performance Check Dye Kit

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