FDA.reportPublic FDA data

Affymetrix

Primary DI
00856826006029
Brand
Affymetrix
Company
Affymetrix, Inc.
Model
00-0335
Catalog number
00-0335
Device description
GeneChip™ Fluidics Station FS450Dx v2
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
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
00856826006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856826006029008568260060298568260060290856826006029

GMDN Terms#

Term, Definition table
TermDefinition
Microarray analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes and/or digital imaging techniques.

Regulatory Flags#

DUNS number
804682573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
00856826006128Affymetrix9021099021092016-09-23
00856826006135Affymterix9021109021102016-09-23
00856826006142Affymetrix9021079021072016-09-23
00856826006159Affymetrix9021089021082016-09-23
00856826006166Affymetrix9021119021112016-09-23
00085626006104Affymetrix9020909020902016-09-23

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04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
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00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
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04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
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15420045517059Aptima®Hologic, Inc.NSU2024-12-19
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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
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