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Gold Standard Diagnostics RPR Reagent Pack
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref GSD34-1600-R
Identity
- Trade Name
- Gold Standard Diagnostics RPR Reagent Pack EUDAMEDFDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Gold Standard Diagnostics RPR Reagent Pack EUDAMEDRapid Plasma Reagin (RPR) Reagent Pack FDA UDI
- Model / Reference
- GSD34-1600-R EUDAMEDFDA UDI
- Description
- Rapid Plasma Reagin (RPR) Reagent Pack FDA UDI
Identifiers
- Catalog Number
- GSD34-1600-R FDA UDI
- Primary DI / UDI-DI
- B350GSD341600R0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B350GSD341600R0 EUDAMED
- EMDN Code
- W0105010399 SYPHILIS REAGENTS OTHER EUDAMED
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- 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
Yes
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 RPR Reagent Pack by Gold Standard Diagnostics, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-B350GSD341600R0 | 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 51faa3fd-ee94-4c8f-af6e-67ec0f025aac 61 fields · synced Jun 20, 2026
- FDA UDI e68ad68b-c187-4228-a993-5c15de1b9196 35 fields · synced May 30, 2026