Identity
- Trade Name
- Tinaquant Apolipoprotein A1 ver2 FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 5950686190 FDA UDI
Identifiers
- Catalog Number
- 5950686190 FDA UDI
- Primary DI / UDI-DI
- 04015630928651 FDA UDI
- FDA Product Code
- DER FDA UDI
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5580 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
No
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
Tinaquant Apolipoprotein A1 ver2 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry.
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- 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
- APO A-I — Randox Laboratories, Ltd. · Class I
- APO A-I — Randox Laboratories, Ltd. · 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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 9c8a7315-4e45-49b9-a8fb-7b378958b2ff 34 fields · synced Jun 7, 2026