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Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref GSD01-1600-5C
Identity
- Trade Name
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C EUDAMEDFDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C EUDAMEDFDA UDI
- Model / Reference
- GSD01-1600-5C EUDAMEDFDA UDI
- Description
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C FDA UDI
Identifiers
- Catalog Number
- GSD01-1600-5C FDA UDI
- Primary DI / UDI-DI
- B350GSD0116005C0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B350GSD0116005C0 EUDAMED
- 510(k) Number
- K150358 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- EMDN Code
- W0105010399 SYPHILIS REAGENTS OTHER EUDAMED
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C by Gold Standard Diagnostics, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B350GSD0116005C0 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED db6c0eca-078b-475a-ae28-c6f0b9d63574 61 fields · synced Jun 8, 2026
- FDA UDI 701a22cf-0bb7-46a2-9755-06e970eff1b7 36 fields · synced May 30, 2026