Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, control FDA UDI
- Device Name
- ARCHITECT AFP Controls FDA UDI
- Model / Reference
- 3P36-10 FDA UDI
- Description
- ARCHITECT AFP Controls FDA UDI
Identifiers
- Catalog Number
- 03P3610 FDA UDI
- Primary DI / UDI-DI
- 00380740081294 FDA UDI
- FDA Product Code
- LOK FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) IVD, control FDA UDI
Classification
- Device Class
- Class III 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: Alpha-fetoprotein (AFP) IVD, control
Architect by Abbott Ireland Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-fetoprotein (AFP) IVD, control.
- Alpha-Fetoprotein Control Slides — BIO SB, INC. · Class I
- IMMULITE® Systems AFP Calibration Verification Material — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Alpha-Fetoprotein Control Slides — BIO SB, INC. · Class I
- Atellica IM AFP MCM — Siemens Healthcare Diagnostics · Class I
- Alpha-Fetoprotein control slides — BIO SB, INC. · Class I
- ADVIA Centaur® Systems, ACS 180® Systems AFP MCM — Siemens Healthcare Diagnostics · Class I
- AIA-PACK AFP Calibration Verification Test Set — Tosoh Corp. · Class I
- Alinity — Abbott Ireland Diagnostics · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 03b52401-fa3f-4fe9-ac1a-576aaa6216eb 36 fields · synced Jun 1, 2026