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System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
FDA product code PFX · Class 2 · Immunology
19
Registered devices
2
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
Affymetrix — Affymetrix, Inc.GenetiSure Dx Labeling Kit Purification Columns — AGILENT TECHNOLOGIES, INC.Affymetrix — Affymetrix, Inc.Applied Biosystems — Affymetrix, Inc.Affymetrix — Affymetrix, Inc.GenetiSure Dx Cot-1 Human DNA — AGILENT TECHNOLOGIES, INC.GenetiSure Dx Labeling Kit — AGILENT TECHNOLOGIES, INC.Affymetrix — Affymetrix, Inc.Affymetrix — Affymetrix, Inc.Affymetrix — Affymetrix, Inc.GenetiSure Dx Wash Buffer 1 — AGILENT TECHNOLOGIES, INC.Affymetrix — Affymetrix, Inc.Affymetrix — Affymetrix, Inc.Affymetrix — Affymetrix, Inc.GenetiSure Dx Wash Buffer 2 — AGILENT TECHNOLOGIES, INC.GenetiSure Dx Postnatal Assay — AGILENT TECHNOLOGIES, INC.Affymetrix — Affymetrix, Inc.GenetiSure Dx Hybridization Kit — AGILENT TECHNOLOGIES, INC.Affymterix — Affymetrix, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Agilent Technologies, Inc. | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a m |
| 2016-04-14 | Affymetrix Inc | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. |
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