Panels › Microbiology › Product code PAB · Class 2
Cytomegalovirus (Cmv) Dna Quantitative Assay
Regulation 866.3180
1510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PAB
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic, Inc. | 1 | 1 |
| Abbott Molecular, Inc. | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2024 | Hologic, Inc. Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstit Open, Classified |
PAB | None listed |
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