Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- ARCHITECT MULTIGENT SI Units / Alternate Units e-Assay CD-ROM version 9.0 FDA UDI
- Model / Reference
- 8K51-09 FDA UDI
- Description
- ARCHITECT MULTIGENT SI Units / Alternate Units e-Assay CD-ROM version 9.0 FDA UDI
Identifiers
- Catalog Number
- 08K5109 FDA UDI
- Primary DI / UDI-DI
- 00380740180638 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory instrument/analyser application software IVD
Architect by Abbott Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory instrument/analyser application software IVD.
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 48efbb96-f204-4770-bfe0-b35e1f1c2c7f 35 fields · synced May 31, 2026