FDA.reportPublic FDA data

Affymetrix

Primary DI
00856826006128
Brand
Affymetrix
Company
Affymetrix, Inc.
Model
902109
Catalog number
902109
Device description
CytoScan™ Dx Post-PCR -20°C MOD F L H
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00856826006128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856826006128008568260061288568260061280856826006128

GMDN Terms#

Term, Definition table
TermDefinition
Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative detection of genome copy number variations (CNV) associated with intellectual disability, developmental delay, congenital anomalies, and/or dysmorphic features, using a nucleic acid technique (NAT).

Regulatory Flags#

DUNS number
804682573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856826006203Applied Biosystems1.06114032024-12-24
00856826006210Applied Biosystems2.16105252024-10-30
00856826006104Affymetrix9020909020902016-09-23
00856826006029Affymetrix00-033500-03352016-09-23
00856826006036Affymetrix00-033600-03362016-09-23
00856826006043Affymetrix00-014600-01462016-09-23
00856826006050Affymetrix2.16105332016-09-23
00856826006067Affymetrix1.26104662016-09-23
00856826006074Affymetrix1.26105252016-09-23
00856826006081Affymetrix5209695209692016-09-23
00856826006098Affymetrix9021509021502016-09-23
00856826006111Affymetrix9020919020912016-09-23
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
00856826006111AffymetrixAffymetrix, 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