Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT Ferritin Reagent Kit (500T) FDA UDI
- Model / Reference
- 7K59-35 FDA UDI
- Description
- ARCHITECT Ferritin Reagent Kit (500T) FDA UDI
Identifiers
- Catalog Number
- 07K5935 FDA UDI
- Primary DI / UDI-DI
- 00380740105976 FDA UDI
- FDA Product Code
- DBF FDA UDI
- GMDN Term
- Ferritin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5340 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
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: Ferritin IVD, kit, chemiluminescent immunoassay
Architect by Abbott Ireland — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, kit, chemiluminescent immunoassay.
- Elecsys Ferritin — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Atellica IM Fer — Siemens Healthcare Diagnostics · Class II
- Dimension Vista® Flex® reagent cartridge FERR — Siemens Healthcare Diagnostics · Class II
- Elecsys Ferritin — Roche Diagnostics Corp. · Class II
- Tinaquant Ferritin Gen4 — Roche Diagnostics Corp. · Class II
- Tinaquant Ferritin Gen4 — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® FER — Siemens Healthcare Diagnostics · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Ireland
Sources (1)
- FDA UDI 91a32274-1155-4469-8417-64e6052be7bf 36 fields · synced Jun 6, 2026