PMA P210022S007

Device
Alinity m CMV
Applicant
Abbott Molecular, Inc.
PMA number
P210022
Supplement
S007
Product code
PAB
Decision date
2023-09-14
Classification
Microbiology
Generic name
Cytomegalovirus (cmv) dna quantitative assay
Approval order statement
Add a new component supplier.

Current openFDA PMA Record#

Device
Alinity m CMV
Applicant
Abbott Molecular, Inc.
PMA number
P210022
Supplement
S007
Product code
PAB
Generic name
Cytomegalovirus (cmv) dna quantitative assay
Decision date
2023-09-14
Decision code
OK30
Date received
2023-08-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add a new component supplier.