FDA.reportPublic FDA data

Affymetrix

Primary DI
00856826006050
Brand
Affymetrix
Company
Affymetrix, Inc.
Model
2.1
Catalog number
610533
Device description
Affymetrix Molecular Diagnostic Software (AMDS)
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
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856826006050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856826006050008568260060508568260060500856826006050

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument application software IVDAn individual software program or group of programs, routines or algorithms that add specific data communication, display, processing and/or system integration capabilities to one or more pre-analytical laboratory processing functions (eg. robotic specimen transfer, aliquoting, pipetting, serial dilutions, reagent dispensing, etc) and assay processing functions (microplate washing, incubation control, plate agitation etc) using a series of programmable sequences and data communication facilities to achieve semi-automated throughput. The program applications are restricted to instrument operations and do not generally include data reduction, result interpretation or reporting facilities.

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
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
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
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00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
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00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONNSU2025-06-11
04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYNSU2024-04-02
00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18
00195126000741Aptiva® Instrument System CuvettesINOVA DIAGNOSTICS, INC.NSU2024-03-11