Identity
- Trade Name
- TF FDA UDI
- Generic Name
- Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Intended for the quantitative in vitro determination of Transferrin in Serum FDA UDI
- Model / Reference
- TF7197 FDA UDI
- Description
- Intended for the quantitative in vitro determination of Transferrin in Serum FDA UDI
Identifiers
- Catalog Number
- TF7197 FDA UDI
- Primary DI / UDI-DI
- 05055273206500 FDA UDI
- 510(k) Number
- K002585 FDA UDI
- FDA Product Code
- DDG FDA UDI
- GMDN Term
- Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5880 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: Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Tf by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry.
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- Alinity — ABBOTT IRELAND · Class II
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Cleared under the same submission
K002585 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI a2d09dcb-259e-47b8-bf96-e53775df170e 37 fields · synced May 30, 2026