QUANTA-Lyser® 3000 /IFA

GUDID 08426950865131

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

• Primary Device ID: 08426950865131
• NIH Device Record Key: 3ff185ab-1c14-4e6f-bb8b-ec364f32145a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTA-Lyser® 3000 /IFA
• Version Model Number: VS3002
• 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	08426950865131 [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.

• 08426950454373 - QUANTA Lite® ANA ELISA: 2026-02-09 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL predilu
• 08426950456193 - NOVA Lite® HEp-2 ANA Kit: 2026-02-09 1. 20x Hep- 2 ANA Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate
• 08426950593461 - NOVA Lite® HEp-2 ANA Kit: 2026-02-09 1. 5 x 12-well HEp-2 Substrate Slides 2. 1 x 4mL FITC Anti-Human IgG Conjugate 3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Con
• 08426950593577 - NOVA Lite® ANA Kit with DAPI: 2026-02-09 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI
• 08426950594208 - NOVA Lite® HEp-2 External EB Kits: 2026-02-09 1. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Con
• 08426950594857 - NOVA Lite® Auto AB Panel: 2026-02-09 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centr
• 08426950595267 - NOVA Lite® HEp-2 External EB Kits: 2026-02-09 1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Contr
• 08426950627692 - QUANTA Flash PR3 Reagents: 2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge