Panels › Immunology › Product code PFX · Class 2
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Regulation 866.5920
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in PFX
| Company | 510(k)s | Recalls |
|---|---|---|
| Affymetrix, Inc. | 1 | 1 |
| Agilent Technologies, Inc. | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2025 | Agilent Technologies, Inc. GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). Open, Classified |
PFX | K163367 |
| Apr 14, 2016 | Affymetrix Inc CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software.
The CytoScan Dx Assay consists of five reagent modules, wash buff Terminated |
PFX | None listed |
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