Affymterix 902110

GUDID 00856826006135

AFFYMETRIX, INC.

Human genomic analysis interpretive software
Primary Device ID00856826006135
NIH Device Record Key354a37c9-c0af-40f7-ad5d-4b60be944dd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffymterix
Version Model Number902110
Catalog Number902110
Company DUNS804682573
Company NameAFFYMETRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856826006135 [Primary]

FDA Product Code

PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by AFFYMETRIX, INC.

00856826006210 - Applied Biosystems2024-11-07 Chromosome Analysis Suite Dx Software
00856826006104 - CytoScan Dx WS A2020-02-10
00856826006029 - Affymetrix2018-03-29
00856826006036 - Affymetrix2018-03-29
00856826006043 - Affymetrix2018-03-29
00856826006050 - Affymetrix2018-03-29
00856826006067 - Affymetrix2018-03-29
00856826006074 - Affymetrix2018-03-29

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