QUANTA Flash® aCL IgA Reagents

GUDID 08426951289288

1. 1 QUANTA Flash aCL IgA Reagent Cartridge 2. 1 QUANTA Flash aCL IgA Calibrator 1 3. 1 QUANTA Flash aCL IgA Calibrator 2

INOVA DIAGNOSTICS, INC.

Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID08426951289288
NIH Device Record Key19f5756c-fba8-4574-80d6-eee8b430862d
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUANTA Flash® aCL IgA Reagents
Version Model Number701225
Company DUNS188354831
Company NameINOVA DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-545-9495
Emailsupport@inovadx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951289288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIDSystem, Test, Anticardiolipin Immunological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-07
Device Publish Date2019-09-27

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Trademark Results [QUANTA Flash]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTA FLASH
QUANTA FLASH
77963733 4071260 Live/Registered
Inova Diagnostics, Inc.
2010-03-19
QUANTA FLASH
QUANTA FLASH
77729358 4067677 Live/Registered
Inova Diagnostics, Inc.
2009-05-05

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