Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Carbamazepine therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- ARCHITECT iCarbamazepine Calibrators FDA UDI
- Model / Reference
- 1P36-01 FDA UDI
- Description
- ARCHITECT iCarbamazepine Calibrators FDA UDI
Identifiers
- Catalog Number
- 01P3601 FDA UDI
- Primary DI / UDI-DI
- 00380740001834 FDA UDI
- 510(k) Number
- K103627 FDA UDI
- FDA Product Code
- DKB FDA UDIKLT FDA UDI
- GMDN Term
- Carbamazepine therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 FDA UDI862.3645 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: Carbamazepine therapeutic drug monitoring IVD, calibrator
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbamazepine therapeutic drug monitoring IVD, calibrator.
Cleared under the same submission
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
Sources (1)
- FDA UDI 7e15f048-aa84-4e6d-8c24-daef33372971 37 fields · synced May 30, 2026