Identity
- Trade Name
- VERSANT HCV Control 2.0 Kit (LiPA) FDA UDI
- Generic Name
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- VERSANT HCV Control 2.0 Kit FDA UDI
- Model / Reference
- 10719668 FDA UDI
- Description
- VERSANT HCV Control 2.0 Kit FDA UDI
Identifiers
- Catalog Number
- 10719668 FDA UDI
- Primary DI / UDI-DI
- 00630414000510 FDA UDI
- PMA Number
- P160016 FDA UDI
- FDA Product Code
- OBF FDA UDI
- GMDN Term
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3170 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
VERSANT HCV Control 2.0 Kit (LiPA) by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 System — Roche Diagnostics Corp. · Class II
- Aptima® — Hologic, Inc. · Class II
- COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 — Roche Molecular Systems, Inc. · Class II
- GeneXpert® — CEPHEID · Class II
- cobas® HCV — Roche Molecular Systems, Inc. · Class II
- COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0 — Roche Molecular Systems, Inc. · Class II
- RealTime — Abbott Molecular · Class II
- Alinity m — Abbott Molecular · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b9ce7405-43d3-4b60-8348-1532c4103019 36 fields · synced May 31, 2026