QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator

Basic Information

• Brand Name: QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator
• Primary DI: 08426950865100
• Version / Model: VS3000i
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 1
• Public Version Date: 2024-03-19
• Public Version Status: New
• Public Device Record Key: f6293c03-4b96-4ffe-a498-492ec03cc13c

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950865100	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]