De Novo DEN130018

Device: CYTOSCAN(R) DX
Contact: eric fung
De Novo number: DEN130018
Product code: PFX
Regulation: 866.5920
Classification name: system, microarray-based, genome-wide, postnatal chromosomal abnormality detection
Decision: granted (DENG)
Decision date: 2014-01-17
Date received: 2013-12-18
Classification advisory: Immunology
Review advisory: Pathology
Type: Post-NSE

Current FDA Classification#

Product code: PFX
Device name: System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Medical specialty: Immunology
Device class: 2
Regulation: 866.5920
Implant: N
Life sustain/support: N

Primary DI, Device, Company table
Primary DI	Device	Company	Published
00856826006210	Applied Biosystems	Affymetrix, Inc.	2024-10-30
05700571112618	GenetiSure Dx Labeling Kit Purification Columns	AGILENT TECHNOLOGIES, INC.	2017-11-08
05700571108697	GenetiSure Dx Postnatal Assay	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112601	GenetiSure Dx Labeling Kit	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112625	GenetiSure Dx Hybridization Kit	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112632	GenetiSure Dx Wash Buffer 1	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112649	GenetiSure Dx Wash Buffer 2	AGILENT TECHNOLOGIES, INC.	2017-11-07
05700571112656	GenetiSure Dx Cot-1 Human DNA	AGILENT TECHNOLOGIES, INC.	2017-11-07
00856826006074	Affymetrix	Affymetrix, Inc.	2016-09-23
00085626006104	Affymetrix	AFFYMETRIX, INC.	2016-09-23
00856826006166	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006159	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006142	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006135	Affymterix	Affymetrix, Inc.	2016-09-23
00856826006128	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006111	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006098	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006081	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006067	Affymetrix	Affymetrix, Inc.	2016-09-23
00856826006104	Affymetrix	Affymetrix, Inc.	2016-09-23