Alinity m CMV

FDA Premarket Approval P210022

Pre-market Approval Supplement Details

DeviceAlinity m CMV
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantAbbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Date Received06/01/2021 Decision Date05/05/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No
Date Received2021-06-01
Decision Date2022-05-05
PMAP210022
SupplementS
Product CodePAB 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Molecular, Inc.
1300 E. Touhy Avenue
des Plaines, IL 60018 PMA NumberP210022 Date Received06/01/2021 Decision Date05/05/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Alinity M CMV. Alinity M CMV AMP KitThe Alinity M CMV Assay Is An In Vitro Polymerase Chain Reaction (PCR) Assay For Use With The Automated Alinity M System To Quantitate Cytomegalovirus (CMV) DNA In Human EDTA Plasma. The Alinity M CMV Assay Is Intended For Use As An Aid In The Management Of Hematopoietic Stem Cell Transplant And Solid Organ Transplant Patients Who Are Undergoing Anti-cytomegalovirus Therapy. The Alinity M CMV Assay Can Be Used To Assess Virological Response To Anti-cytomegalovirus Therapy. The Results From The Alinity M CMV Test Must Be Interpreted Within The Context Of All Relevant Clinical And Laboratory Findings. The Alinity M CMV Test Is Not Intended As A Screening Test For The Presence Of CMV DNA In Blood Or Blood Products.Alinity M CTRL KitThe Alinity M CMV Controls Are For Validity Determination Of The Quantitative Alinity M CMV Assay On The Automated Alinity M System. These Controls Are Intended To Be Used With The Alinity M CMV Assay; Refer To The Assay Package Insert For Additional Information.Alinity M CAL KitThe Alinity M CMV Calibrators Are For Calibration For The Alinity M CMV Assay On The Automated Alinity M System When Used For The Quantitative Determination Of CMV DNA. The Calibrators Are Intended To Be Used With The Alinity M CMV Assay; Refer To The Assay Package Insert For Additional Information. Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P210022Original Filing

NIH GUDID Devices

Device IDPMASupp
00884999049956 P210022 000
00884999049611 P210022 000
00884999049604 P210022 000
00884999049598 P210022 000

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