FDA PMA
FDA Class 2
30-Day Notice Accepted
🇺🇸 United States
Cytomegalovirus (Cmv) Dna Quantitative Assay
PMA: P110037
·
Supplement: S026
·
Decision May 13, 2016
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Trade Name
- COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
- PMA Number
- P110037
- Supplement Number
- S026
- Device Class
- FDA Class 2
- Product Code
- PAB
- Generic Name
- Cytomegalovirus (cmv) dna quantitative assay
- Regulation Number
- 866.3180
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 13, 2016
- Date Received
- April 18, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.
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 |
|---|---|---|---|
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | FDA class 2 | Microbiology |