Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) IVD, calibrator FDA UDI
- Device Name
- ARCHITECT CA19-9XR Calibrators FDA UDI
- Model / Reference
- 2K91-01 FDA UDI
- Description
- ARCHITECT CA19-9XR Calibrators FDA UDI
Identifiers
- Catalog Number
- 02K9101 FDA UDI
- Primary DI / UDI-DI
- 00380740003555 FDA UDI
- FDA Product Code
- JIT FDA UDIJJX FDA UDINIG FDA UDI
- GMDN Term
- Cancer antigen 19-9 (CA19-9) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1660 FDA UDI866.6010 FDA UDI
- Commercial Distribution
- Not 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
Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 78f3630e-480d-4a81-afe6-a6fd73742a96 37 fields · synced May 31, 2026