| Device | Alinity m CMV |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Abbott 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 Received | 2021-06-01 |
| Decision Date | 2022-05-05 |
| PMA | P210022 |
| Supplement | S |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott 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: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210022 | Original Filing | |
| S002 | 2022-11-03 | 30-day Notice |
| S001 | 2022-05-18 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999049956 | P210022 | 000 |
| 00884999049611 | P210022 | 000 |
| 00884999049604 | P210022 | 000 |
| 00884999049598 | P210022 | 000 |