Identity
- Trade Name
- MININEPH™ Human Rheumatoid Factor Kit FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- ZK151.L.R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700011471 FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
MININEPH™ Human Rheumatoid Factor Kit by The Binding Site Group — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI ae67a73a-0428-452a-907f-d0335dce9c3c 35 fields · synced May 30, 2026