QUANTA Flash RF IgM Reagents

GUDID 08426950845249

1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations: a. Rabbit pAb coated paramagnetic beads. b. Assay buffer - colored pink, containing proteing stabilizers and preservatives. c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives.

INOVA DIAGNOSTICS, INC.

Rheumatoid factor IVD, kit, chemiluminescent immunoassay
Primary Device ID08426950845249
NIH Device Record Key7a388e60-7dd7-4165-9124-eb7f69fc977c
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUANTA Flash RF IgM Reagents
Version Model Number701340
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
GS108426950845249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHRSystem, Test, Rheumatoid Factor

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-30
Device Publish Date2019-09-20

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