Identity
- Trade Name
- N Antiserum to Human a1-Antitrypsin FDA UDI
- Generic Name
- Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems FDA UDI
- Model / Reference
- 10446311 FDA UDI
- Description
- Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems FDA UDI
Identifiers
- Catalog Number
- OSAZ09 FDA UDI
- Primary DI / UDI-DI
- 00842768009921 FDA UDI
- 510(k) Number
- K053072 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
N Antiserum to Human a1-Antitrypsin by Siemens Healthcare Diagnostics Products Ltd — 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.
- Tinaquant 1Antitrypsin ver2 — Roche Diagnostics Corp. · Class II
- Optilite Alpha-1-antitrypsin Kit — The Binding Site Group · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Tinaquant 1Antitrypsin ver2 — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica CH AAT — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K053072 also covers:
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 9344d6af-5b9b-4a85-87dc-eaf9eea16e51 37 fields · synced Jun 6, 2026