Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali

FDA Premarket Approval P160044 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceAbbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-19
Decision Date2022-06-09
PMAP160044
SupplementS004
Product CodePAB 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressABBOTT MOLECULAR
1300 East Touhy Avenue
des Plaines, IL 60018 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Manufacturing Scale-up Of A Kit Component

Supplemental Filings

Supplement NumberDateSupplement Type
P160044Original Filing
S004 2022-05-19 30-day Notice
S003 2021-02-05 30-day Notice
S002 2019-04-10 30-day Notice
S001 2017-06-27 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999047297 P160044 000
00884999045798 P160044 000
00884999045781 P160044 000
00884999045774 P160044 000

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