PMA P160044S002
- Device
- Abbott RealTime CMV
- Applicant
- Abbott Molecular
- PMA number
- P160044
- Supplement
- S002
- Product code
- PAB
- Decision date
- 2019-05-15
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Implement additional QC to device accessory kits.
Current openFDA PMA Record#
- Device
- Abbott RealTime CMV
- Applicant
- Abbott Molecular
- PMA number
- P160044
- Supplement
- S002
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2019-05-15
- Decision code
- OK30
- Date received
- 2019-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement additional QC to device accessory kits.