FLU/RSV Positive Control 751110

GUDID 00840733101977

FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program

MERIDIAN BIOSCIENCE, INC.

Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control
Primary Device ID00840733101977
NIH Device Record Keydb9fefcd-9c8a-4a2d-9bc9-a746f737af0d
Commercial Distribution Discontinuation2021-05-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFLU/RSV Positive Control
Version Model Number751110
Catalog Number751110
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, 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 Usefalse
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

Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-06-21
Device Publish Date2020-11-17

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