Identity
- Trade Name
- ADVIA Centaur® Systems QC aHAVT FDA UDI
- Generic Name
- Hepatitis A virus total antibody IVD, control FDA UDI
- Device Name
- HAV Total - CENTAUR - CONS - 2x2x7mL FDA UDI
- Model / Reference
- 10322682 FDA UDI
- Description
- HAV Total - CENTAUR - CONS - 2x2x7mL FDA UDI
Identifiers
- Catalog Number
- 5500077 FDA UDI
- Primary DI / UDI-DI
- 00630414481883 FDA UDI
- PMA Number
- P040017 FDA UDI
- FDA Product Code
- LOL FDA UDI
- GMDN Term
- Hepatitis A virus total antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3310 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: Hepatitis A virus total antibody IVD, control
ADVIA Centaur® Systems QC aHAVT by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis A virus total antibody IVD, control.
- LIAISON® Control anti-HAV — Diasorin Inc.
- VITROS — Ortho-Clinical Diagnostics · Class I
- Atellica IM aHAVT QC — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® aHAVT QC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
P040017 also covers:
- ADVIA Centaur® aHAVT — Siemens Healthcare Diagnostics
- ADVIA Centaur® aHAVT — Siemens Healthcare Diagnostics
- ADVIA Centaur® aHAVT QC — Siemens Healthcare Diagnostics
- Atellica IM aHAVT — Siemens Healthcare Diagnostics
- Atellica IM aHAVT — Siemens Healthcare Diagnostics
- Atellica IM aHAVT QC — Siemens Healthcare Diagnostics
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
Sources (1)
- FDA UDI 1a9324f6-d864-477e-8297-e7d2d665b33c 37 fields · synced May 30, 2026