FDA PMA
FDA Class 2
30-Day Notice Accepted
🇺🇸 United States
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
PMA: P150015
·
Supplement: S033
·
Decision Sep 4, 2019
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
- cobas HCV
- PMA Number
- P150015
- Supplement Number
- S033
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 4, 2019
- Date Received
- August 6, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Increase the scale of bulk manufacturing of a reagent component.
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 |