illumigene Mycoplasma External Control Kit 279940

GUDID 00840733101144

The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program.

MERIDIAN BIOSCIENCE, INC.

Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control Mycoplasma pneumoniae nucleic acid IVD, control
Primary Device ID00840733101144
NIH Device Record Keyed74a0b5-f96e-4e2a-aabe-834adb73f105
Commercial Distribution StatusIn Commercial Distribution
Brand Nameillumigene Mycoplasma External Control Kit
Version Model Number279940
Catalog Number279940
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

Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101144 [Primary]

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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