Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- ARCHITECT cSYSTEMS ICT MODULE FDA UDI
- Model / Reference
- 9D28-03 FDA UDI
- Description
- ARCHITECT cSYSTEMS ICT MODULE FDA UDI
Identifiers
- Catalog Number
- 09D2803 FDA UDI
- Primary DI / UDI-DI
- 00380740019327 FDA UDI
- FDA Product Code
- JJE FDA UDICEM FDA UDIJGS FDA UDICGZ FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI862.1600 FDA UDI862.1665 FDA UDI862.1170 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Architect by Abbott Laboratories, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 85b1ee2f-ea0e-4f0e-ad13-1e2924ac0020 37 fields · synced May 30, 2026