FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
PMA: P020022
·
Supplement: S007
·
Decision Apr 14, 2009
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Trade Name
- VERSANT HCV RNA 3.0 (BDNA) WITH VERSANT 440 MOLECULAR SYSTEM
- PMA Number
- P020022
- Supplement Number
- S007
- Device Class
- FDA Class 2
- Product Code
- MZP
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Regulation Number
- 866.3170
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 14, 2009
- Date Received
- March 20, 2009
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR SOFTWARE CHANGES TO THE 440 SYSTEM SOFTWARE AND DMS SOFTWARE (RELEASE 3).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | FDA class 2 | Microbiology |