Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Creatinine IVD, kit, spectrophotometry FDA UDI
- Device Name
- Creatinine (Enzymatic) FDA UDI
- Model / Reference
- 8L24-41 FDA UDI
- Description
- Creatinine (Enzymatic) FDA UDI
Identifiers
- Catalog Number
- 08L2441 FDA UDI
- Primary DI / UDI-DI
- 00380740017699 FDA UDI
- FDA Product Code
- JFY FDA UDI
- GMDN Term
- Creatinine IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Creatinine IVD, kit, spectrophotometry
Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Creatinine Jaff Gen2 — Roche Diagnostics Corp. · 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 |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI daa0c472-c9c6-44f2-8190-6587d7836577 36 fields · synced Jun 8, 2026