RSV Positive Control 751110

GUDID 00840733103476

RSV Positive Control is an external control reagent to be used with 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 ID00840733103476
NIH Device Record Key81e094af-3244-4047-a578-529d83a7eba1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRSV 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 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

Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone800-343-3858
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733103476 [Primary]

FDA Product Code

MJXKit, Serological, Positive Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-28
Device Publish Date2021-06-18

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