Identity
- Trade Name
- Detector RPR FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- A macroscopic card test for the qualitative detection and semi-quantitative determination of syphilis in human plasma or serum FDA UDI
- Model / Reference
- RPR-500NC FDA UDI
- Description
- A macroscopic card test for the qualitative detection and semi-quantitative determination of syphilis in human plasma or serum FDA UDI
Identifiers
- Catalog Number
- RPR-500NC FDA UDI
- Primary DI / UDI-DI
- 10722355001798 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination 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
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
Category: Treponema pallidum reagin antibody IVD, kit, agglutination
Detector RPR by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 8782fae5-8b17-4a4b-a15b-c71e78f360e5 36 fields · synced Jun 8, 2026