Identity
- Trade Name
- APO A-I FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma FDA UDI
- Model / Reference
- LP2989 FDA UDI
- Description
- Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma FDA UDI
Identifiers
- Catalog Number
- LP2989 FDA UDI
- Primary DI / UDI-DI
- 05055273204391 FDA UDI
- 510(k) Number
- K950382 FDA UDI
- FDA Product Code
- JHN FDA UDI
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Apo A-I by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry.
- Atellica CH APO A1 — Siemens Healthcare Diagnostics · Class I
- Tinaquant Apolipoprotein A1 ver2 — Roche Diagnostics Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Alinity — Abbott · Class II
- Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS — The Binding Site Group · Class I
- ADVIA® Chemistry APO A1 Reagents — Siemens Healthcare Diagnostics · Class I
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Antiserum to Human Apolipoprotein A-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 20c640d7-5fe4-4461-b294-2a601afcd0da 37 fields · synced May 29, 2026