FDA.reportPublic FDA data

Affymetrix

Primary DI
00856826006111
Brand
Affymetrix
Company
Affymetrix, Inc.
Model
902091
Catalog number
902091
Device description
CytoScan™ Dx WS B
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856826006111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856826006111008568260061118568260061110856826006111

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive softwareAn interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used in the assessment of adverse health condition risk, disease prevention, and/or health management. It can also be used by the patient for lifestyle guidance as pertains to their genomic profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804682573
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856826006050Affymetrix2.16105332016-09-23
00856826006067Affymetrix1.26104662016-09-23
00856826006104Affymetrix9020909020902016-09-23
00856826006203Applied Biosystems1.06114032024-12-24
00856826006210Applied Biosystems2.16105252024-10-30
00856826006029Affymetrix00-033500-03352016-09-23
00856826006036Affymetrix00-033600-03362016-09-23
00856826006043Affymetrix00-014600-01462016-09-23
00856826006074Affymetrix1.26105252016-09-23
00856826006081Affymetrix5209695209692016-09-23
00856826006098Affymetrix9021509021502016-09-23
00856826006128Affymetrix9021099021092016-09-23
00856826006135Affymterix9021109021102016-09-23
00856826006142Affymetrix9021079021072016-09-23
00856826006159Affymetrix9021089021082016-09-23
00856826006166Affymetrix9021119021112016-09-23
00085626006104Affymetrix9020909020902016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856826006210Applied BiosystemsAffymetrix, Inc.PFX2024-10-30
05700571112618GenetiSure Dx Labeling Kit Purification ColumnsAGILENT TECHNOLOGIES, INC.PFX2017-11-08
05700571108697GenetiSure Dx Postnatal AssayAGILENT TECHNOLOGIES, INC.PFX2017-11-07
05700571112601GenetiSure Dx Labeling KitAGILENT TECHNOLOGIES, INC.PFX2017-11-07
05700571112625GenetiSure Dx Hybridization KitAGILENT TECHNOLOGIES, INC.PFX2017-11-07
05700571112632GenetiSure Dx Wash Buffer 1AGILENT TECHNOLOGIES, INC.PFX2017-11-07
05700571112649GenetiSure Dx Wash Buffer 2AGILENT TECHNOLOGIES, INC.PFX2017-11-07
05700571112656GenetiSure Dx Cot-1 Human DNAAGILENT TECHNOLOGIES, INC.PFX2017-11-07
00856826006104AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006067AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006074AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006081AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006098AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006128AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006135AffymterixAffymetrix, Inc.PFX2016-09-23
00856826006142AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006159AffymetrixAffymetrix, Inc.PFX2016-09-23
00856826006166AffymetrixAffymetrix, Inc.PFX2016-09-23
00085626006104AffymetrixAFFYMETRIX, INC.PFX2016-09-23