Identity
- Trade Name
- RF LATEX Test Kit FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum. Kit Contains: 5 ml RF Latex Reagent 10 ml Glycine-Saline Buffer Concentrate 1 ml RF Positive Control 1 ml RF Negative Control 6-ring slide Product Instructions FDA UDI
- Model / Reference
- R-20 FDA UDI
- Description
- Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum. Kit Contains: 5 ml RF Latex Reagent 10 ml Glycine-Saline Buffer Concentrate 1 ml RF Positive Control 1 ml RF Negative Control 6-ring slide Product Instructions FDA UDI
Identifiers
- Catalog Number
- R-20 FDA UDI
- Primary DI / UDI-DI
- B224R201 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
Yes
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
RF LATEX Test Kit by Cenogenics Corp. — 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
- Cenogenics Corp.
Sources (1)
- FDA UDI 051f80f2-f7ab-49e1-99c6-c4d1bba0750a 35 fields · synced May 30, 2026