FDA.reportPublic FDA data

illumigene Mycoplasma External Control Kit

Primary DI
00840733101144
Brand
illumigene Mycoplasma External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
279940
Catalog number
279940
Device description
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.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
OZXMycoplasma Pneumoniae Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OZXMycoplasma Pneumoniae Dna Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101144008407331011448407331011440840733101144

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma pneumoniae nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Mycoplasma pneumoniae bacteria in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(513) 271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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