Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT CA 15-3 Reagent Kit FDA UDI
- Model / Reference
- 02K4427 FDA UDI
- Description
- ARCHITECT CA 15-3 Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 02K4427 FDA UDI
- Primary DI / UDI-DI
- 00380740145323 FDA UDI
- FDA Product Code
- MOI FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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: Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay.
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Lumipulse G CA 15-3 Immunoreaction Cartridges — FUJIREBIO INC.
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics · Class II
- IMMULITE® 2000 Systems BRM BR-MA (CA15-3) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
Sources (1)
- FDA UDI 7b869f75-ed3a-4d77-a39f-d2176dfa0871 36 fields · synced May 30, 2026