Identity
- Trade Name
- PreciControl Anti-HAV II FDA UDI
- Generic Name
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Model / Reference
- 08086672190 FDA UDI
Identifiers
- Catalog Number
- 08086672190 FDA UDI
- Primary DI / UDI-DI
- 07613336129746 FDA UDI
- 510(k) Number
- K190428 FDA UDI
- FDA Product Code
- QCH FDA UDI
- GMDN Term
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 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: Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
PreciControl Anti-HAV II by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control.
- ADVIA Centaur® HAV IgM QC — Siemens Healthcare Diagnostics · Class II
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- VIROTROL — Bio-Rad Laboratories · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — Abbott · Class II
- ARCHITECT — Abbott · Class II
Cleared under the same submission
K190428 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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI ddbd1f3b-98e9-4b9b-876e-c359ae1513b6 35 fields · synced Jun 6, 2026