AFFYMETRIX, INC.

Address:3450 Central Expressway,Santa Clara,CA,95051,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection (PFX) (5)

Premarket Exempt

Clear

Affymetrix - 00856826006128 Catalog Number : 902109

Device Description : CytoScan® Dx Post-PCR -20°C MOD F L H

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymterix - 00856826006135 Catalog Number : 902110

Device Description : CytoScan® Dx Post-PCR 2°-8°C MOD S AH W PB

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006142 Catalog Number : 902107

Device Description : CytoScan® Dx Pre-PCR -20°C MOD R L A

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006159 Catalog Number : 902108

Device Description : CytoScan® Dx Pre-PCR 2°-8°C MOD T E W

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006166 Catalog Number : 902111

Device Description : CytoScan® Dx Post-PCR 15°-30°C MOD E PW

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : No

Device Count : 1

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