Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Microalbumin 500 Tests FDA UDI
- Model / Reference
- 02K9824 FDA UDI
- Description
- Microalbumin 500 Tests FDA UDI
Identifiers
- Catalog Number
- 02K9824 FDA UDI
- Primary DI / UDI-DI
- 00380740190316 FDA UDI
- FDA Product Code
- JIQ FDA UDI
- GMDN Term
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microalbumin IVD, kit, nephelometry/turbidimetry
Architect by Abbott Ireland — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ARCHITECT — Abbott Laboratories, Inc. · Class I
- mALB — Randox Laboratories, Ltd. · Class II
- mALB — Randox Laboratories, Ltd. · Class II
- Atellica CH uALB_2 — Siemens Healthcare Diagnostics · Class I
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 Ireland
Sources (1)
- FDA UDI 1c245d5a-bf12-4425-a791-f7276f6d9d02 36 fields · synced Jun 6, 2026