FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Cytomegalovirus (Cmv) Dna Quantitative Assay
PMA: P110037
·
Supplement: S019
·
Decision May 1, 2015
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
- PMA Number
- P110037
- Supplement Number
- S019
- 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
- Approved
- Decision Code
- APPR
- Decision Date
- May 1, 2015
- Date Received
- February 25, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGES TO THE MAGNETIC GLASS PARTICLE (MGP) REAGENT BOTTLES AND CLOSURES.
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 |