Identity
- Trade Name
- Tina-quant Alpha 1-Acid Glycoprotein Gen.2 FDA UDI
- Generic Name
- Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 03333795190 FDA UDI
Identifiers
- Catalog Number
- 03333795190 FDA UDI
- Primary DI / UDI-DI
- 04015630919529 FDA UDI
- FDA Product Code
- LKL FDA UDI
- GMDN Term
- Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5420 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
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: Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Tina-quant Alpha 1-Acid Glycoprotein Gen.2 by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI ed129003-196e-428f-bd30-d83379bfa274 33 fields · synced May 31, 2026