FDA.reportPublic FDA data

Applied Biosystems

Primary DI
00856826006210
Brand
Applied Biosystems
Company
Affymetrix, Inc.
Model
2.1
Catalog number
610525
Device description
Chromosome Analysis Suite Dx Software
Published
2024-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00856826006210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856826006210008568260062108568260062100856826006210

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 by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804682573
Device count
1
Manufacturing 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
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
00856826006111Affymetrix9020919020912016-09-23
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
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
00856826006111AffymetrixAffymetrix, 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