AFFYMETRIX, INC.

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) (6) Instrumentation For Clinical Multiplex Test Systems (NSU) (4)

Premarket Exempt

No

Clear

Affymetrix - 00856826006029 Catalog Number : 00-0335

Device Description : Affymetrix GeneChip Fluidics Station FS450Dx v2

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

Affymetrix - 00856826006036 Catalog Number : 00-0336

Device Description : GeneChip Scanner GCS 3000Dx v.2

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

Affymetrix - 00856826006043 Catalog Number : 00-0146

Device Description : Autoloader w/EBR- GCS3000Dx

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : NSU

Prescription Use : No

Device Count : 1

Affymetrix - 00856826006050 Catalog Number : 610533

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006067 Catalog Number : 610466

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006074 Catalog Number : 610525

Device Description : Chromosome Analysis Suite Dx Software

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : No

Device Count : 1

Affymetrix - 00856826006081 Catalog Number : 520969

Device Description : CytoScan® Dx Array

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : No

Device Count : 1

Affymetrix - 00856826006098 Catalog Number : 902150

Device Description : CytoScan Dx Array, 6 pk

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

CytoScan Dx WS A - 00856826006104 Catalog Number : 902090

Device Description : CytoScan Dx WS A

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

Affymetrix - 00856826006111 Catalog Number : 902091

Device Description : CytoScan® Dx Wash Solution B

Device Class : 2

Duns Number: 804682573

Premarket Exempt : No

Product Code : PFX

Prescription Use : Yes

Device Count : 1

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