Identity
- Trade Name
- N Latex RF Kit FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN ProSpec® Systems FDA UDI
- Model / Reference
- 10445991 FDA UDI
- Description
- Determination of Rheumatoid factors (RF) in human serum and plasma on the BN II and BN ProSpec® Systems FDA UDI
Identifiers
- Catalog Number
- OPCE03 FDA UDI
- Primary DI / UDI-DI
- 00842768006883 FDA UDI
- 510(k) Number
- K071247 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, nephelometry/turbidimetry
N Latex RF Kit by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rheumatoid factor IVD, kit, nephelometry/turbidimetry.
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- Tinaquant RF II — Roche Diagnostics Corp. · Class II
- Yumizen C1200 Rheumatoid Factor — Horiba Abx · Class II
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- RF — Randox Laboratories, Ltd. · Class II
- Optilite Rheumatoid Factor Kit — The Binding Site Group · Class II
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
Cleared under the same submission
K071247 also covers:
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 2872faea-27f4-44bd-b90e-c99be156819a 37 fields · synced May 30, 2026