Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Insulin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT Insulin Reagent Kit FDA UDI
- Model / Reference
- 8K41-27 FDA UDI
- Description
- ARCHITECT Insulin Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 08K4127 FDA UDI
- Primary DI / UDI-DI
- 00380740017569 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 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
Yes
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 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 4c90c320-91ba-4bab-9437-10be64d00d26 37 fields · synced May 31, 2026