Identity
- Trade Name
- GSD RPR Microtiterplate - 5 pack sleeve FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- GSD RPR Microtiterplate - 5 pack sleeve FDA UDI
- Model / Reference
- GSD05-1600-W FDA UDI
- Description
- GSD RPR Microtiterplate - 5 pack sleeve FDA UDI
Identifiers
- Catalog Number
- GSD05-1600-W FDA UDI
- Primary DI / UDI-DI
- B350GSD051600W0 FDA UDI
- 510(k) Number
- K150358 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Assay container IVD, single-useTreponema pallidum reagin antibody IVD, kit, agglutination
GSD RPR Microtiterplate - 5 pack sleeve by Gold Standard Diagnostics, LLC — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (2)
- FDA UDI e4dbb4e7-01be-4d1b-8c44-539343763f29 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026