Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Salicylate IVD, kit, spectrophotometry FDA UDI
- Device Name
- Salicylate FDA UDI
- Model / Reference
- 3K01-20 FDA UDI
- Description
- Salicylate FDA UDI
Identifiers
- Catalog Number
- 03K0120 FDA UDI
- Primary DI / UDI-DI
- 00380740005306 FDA UDI
- FDA Product Code
- DKJ FDA UDI
- GMDN Term
- Salicylate IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3830 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: Salicylate IVD, kit, spectrophotometry
Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Salicylate IVD, kit, spectrophotometry.
- SALICYLATE-SL Assay — Sekisui Diagnostics, LLC · Class II
- Dimension Vista® Flex® reagent cartridge SAL — Siemens Healthcare Diagnostics · Class II
- Dimension® Flex® reagent cartridge SAL — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott Laboratories, Inc. · 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 Laboratories, Inc.
Sources (1)
- FDA UDI 9a5c4368-3ef9-4894-b3b5-f878744f9bbd 36 fields · synced May 30, 2026