QUANTA Flash® M2 (MIT3) Reagents

GUDID 08426950730101

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, chemiluminescent immunoassay

Primary Device ID	08426950730101
NIH Device Record Key	8d3c040c-c90a-47b3-b370-bbff007bd500
Commercial Distribution Status	In Commercial Distribution
Brand Name	QUANTA Flash® M2 (MIT3) Reagents
Version Model Number	701303
Company DUNS	188354831
Company Name	INOVA DIAGNOSTICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	08426950730101 [Primary]

DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Steralize Prior To Use	false
Device Is Sterile	false

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