QUANTA-Lyser® 3000 ELISA/IFA

GUDID 08426950865094

QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates.

INOVA DIAGNOSTICS, INC.

Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 08426950865094
• NIH Device Record Key: 2a39e91f-1dfc-4b45-a9eb-11270ee78bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA-Lyser® 3000 ELISA/IFA
• Version Model Number: VS3000
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950865094 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by INOVA DIAGNOSTICS, INC.

• 00195126000871 - Aptiva® System Cleaning Solution Kit: 2024-03-26 The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module
• 00195126000741 - Aptiva® Instrument System Cuvettes: 2024-03-19 The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument Syste
• 08426950865094 - QUANTA-Lyser® 3000 ELISA/IFA: 2024-03-19QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates.
• 08426950865094 - QUANTA-Lyser® 3000 ELISA/IFA: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426950865100 - QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426950865131 - QUANTA-Lyser® 3000 /IFA: 2024-03-19 QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a varie
• 08426951307227 - Aptiva® Multi-Analyte Instrument: 2024-03-19 Aptiva System is an automated particle-based multi-analyte analyzer for in vitro diagnostic testing of clincal specimens. The sy
• 08430793040716 - Aptiva® APS IgG Reagent: 2024-03-19 1. Aptiva APS IgG Reagent Cartridge -APS IgG Beads (1x0.5mL) -Assay Buffer (1x17mL) -PE Tracer IgG(1x17mL) -Rehydration Buffer (
• 08430793040761 - Aptiva® APS IgG Calibrators: 2024-03-19 1.Aptiva APS IgG Calibrator 1 (2x0.3mL) 2. Aptiva APS IgG Calibrator 2 (2x0.3mL) 3. Aptiva APS IgG Calibrator 3 (2x0.3mL)