QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator

GUDID 08426950865100

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 ID08426950865100
NIH Device Record Keyf6293c03-4b96-4ffe-a498-492ec03cc13c
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUANTA-Lyser ® 3000 ELISA/IFA+ Incubator
Version Model NumberVS3000i
Company DUNS188354831
Company NameINOVA DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com
Phone1-800-678-0710
EmailTechSupport.na@werfen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950865100 [Primary]

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

Devices Manufactured by INOVA DIAGNOSTICS, INC.

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08426950865100 - QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator2024-03-19QUANTA-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.
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Trademark Results [QUANTA-Lyser]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTA-LYSER
QUANTA-LYSER
79057728 3580869 Live/Registered
Inova Diagnostics, Inc.
2008-07-02

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