Identity
- Trade Name
- Tinaquant 1Antitrypsin ver2 FDA UDI
- Generic Name
- Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 3005771322 FDA UDI
Identifiers
- Catalog Number
- 3005771322 FDA UDI
- Primary DI / UDI-DI
- 04015630916597 FDA UDI
- 510(k) Number
- K010978 FDA UDI
- FDA Product Code
- DEM FDA UDI
- GMDN Term
- Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5130 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: Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Tinaquant 1Antitrypsin ver2 by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry.
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- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Dimension Vista®a1-Antitrypsin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- N Antiserum to Human a1-Antitrypsin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica CH AAT — Siemens Healthcare Diagnostics · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 72c30a09-fc70-489f-9060-4fbc43fd6578 35 fields · synced May 30, 2026