Identity
- Trade Name
- Biokit RPR 500 TESTS FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- 3 x 3.0 ml RPR ANTIGEN 1 x 1.5 ml REACTIVE CONTROL 1 x 1.5 ml MODERATE REACTIVE CONTROL 1 x 1.5 ml NONREACTIVE CONTROL 50 disposable cards 500 dispensing / spreading pipettes 1 antigen dispensing vial 1 antigen dispensing needle FDA UDI
- Model / Reference
- 300625550 FDA UDI
- Description
- 3 x 3.0 ml RPR ANTIGEN 1 x 1.5 ml REACTIVE CONTROL 1 x 1.5 ml MODERATE REACTIVE CONTROL 1 x 1.5 ml NONREACTIVE CONTROL 50 disposable cards 500 dispensing / spreading pipettes 1 antigen dispensing vial 1 antigen dispensing needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950592327 FDA UDI
- 510(k) Number
- K910541 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
Biokit RPR 500 TESTS by Biokit, S.a. — 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
- Biokit, S.a.
Sources (1)
- FDA UDI 0611d9ed-bdb6-4075-9add-61daa7150e28 36 fields · synced Jun 1, 2026