FDA.reportPublic FDA data

Verigene® Processor

Primary DI
00857573006386
Brand
Verigene® Processor
Company
NANOSPHERE, INC.
Model
10-0000-04
Device description
The Verigene® Processor is an instrument which internalizes all of the functions required to process a Test Cartridge as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070597000VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNanosphere, Inc.2007-10-11NSU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101506PrimaryGS10
00857573006386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101506008404871015068404871015060840487101506
00857573006386008575730063868575730063860857573006386

GMDN Terms#

Term, Definition table
TermDefinition
Multiplex analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-837-4436productsupport@nanosphere.us
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
164757242
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-0012016-09-23
00857573006348Hypercoagulation Panel (HC) Sample Buffer30-001-0012016-09-23
00857573006133Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge20-006-0202016-09-23
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge20-006-0242016-09-23
00857573006232Respiratory Virus Plus (RV+) Extraction Tray20-009-0202016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction Tray20-009-0242016-09-23
00857573006294Respiratory Virus Plus (RV+) Amplification Tray20-011-0202016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification Tray20-011-0242016-09-23
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge20-006-0182016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction Tray20-009-0182016-09-23
00857573006287Gram-Positive Blood Culture (BC-GP) Utility Tray20-011-0182016-09-23
00857573006003 Verigene® Reader 10-0000-022016-09-23
00857573006010 Verigene® Processor SP 10-0000-072016-09-23
00857573006393 Verigene® Reader (Refurbished)10-0000-02R2016-11-04
00857573006409 Verigene® Processor SP (Refurbished)10-0000-07R2016-11-04
00857573006041Enteric Pathogens (EP) Nucleic Acid Test Cartridge20-006-0232016-09-23
00857573006058Enteric Pathogens (EP) Extraction Tray20-009-0232016-09-23
00857573006065Enteric Pathogens (EP) Stool Sample Preparation Kit30-002-0232016-09-23
00857573006089Enteric Pathogens (EP) Amplification Tray20-011-0232016-09-23
00857573006140Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge20-006-0212016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
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
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
08033891322670CHORUS EVODIESSE DIAGNOSTICA SENESE SPANSU2025-07-01
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