Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Apolipoprotein B FDA UDI
- Model / Reference
- 9D93-22 FDA UDI
- Description
- Apolipoprotein B FDA UDI
Identifiers
- Catalog Number
- 09D9322 FDA UDI
- Primary DI / UDI-DI
- 00380740175146 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 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: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry.
- N Antiserum to Human Apolipoprotein B — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Tinaquant Apolipoprotein B ver2 — Roche Diagnostics Corp. · Class II
- Tinaquant Apolipoprotein B ver2 — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- APO B — Randox Laboratories, Ltd. · Class I
- APO B — Randox Laboratories, Ltd. · Class I
- Tina-quant Apolipoprotein B ver.2 — Roche Diagnostics Corp. · Class II
- Atellica CH APO B — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI fd0d802f-3357-417d-9699-8cda8a6a042a 36 fields · synced May 30, 2026