Identity
- Trade Name
- Rheumajet RF 100 TESTS FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- 2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES FDA UDI
- Model / Reference
- 3000-7033 FDA UDI
- Description
- 2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950589334 FDA UDI
- 510(k) Number
- K910539 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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: Rheumatoid factor IVD, kit, agglutination
Rheumajet RF 100 TESTS by Biokit, S.a. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K910539 also covers:
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
- Biokit, S.a.
Sources (2)
- FDA UDI 08c421ca-6430-4400-8895-85b692924daf 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026