Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Uric acid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Uric Acid2 640 Tests FDA UDI
- Model / Reference
- 04U0920 FDA UDI
- Description
- Uric Acid2 640 Tests FDA UDI
Identifiers
- Catalog Number
- 04U0920 FDA UDI
- Primary DI / UDI-DI
- 00380740158378 FDA UDI
- FDA Product Code
- KNK FDA UDI
- GMDN Term
- Uric acid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1775 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uric acid IVD, kit, spectrophotometry
Alinity by Abbott Ireland — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, kit, spectrophotometry.
- ADVIA® Chemistry UA Uric Acid Reagents — Siemens Healthcare Diagnostics · Class I
- ADVIA® Chemistry UA_c Uric Acid Reagents, Concentrated — Siemens Healthcare Diagnostics · Class I
- Uric Acid ver.2 — Roche Diagnostics Corp. · Class I
- ADVIA® Chemistry UA Uric Acid Reagents — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212 — Carolina Liquid Chemistries Corp. · Class I
- URIC ACID MONO SL — VITALSCIENTIFIC
- Uric Acid LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- ARCHITECT — Abbott · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Ireland
Sources (1)
- FDA UDI 3f727116-94f9-4349-a160-ab6520fcd0cc 36 fields · synced May 30, 2026