FDA.reportPublic FDA data

illumigene Pertussis External Control Kit

Primary DI
00840733101137
Brand
illumigene Pertussis External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
279930
Catalog number
279930
Device description
The illumigene Pertussis External Control Kit contains Positive Control Reagent for use with the illumigene Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. 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
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101137008407331011378407331011370840733101137

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis 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 Bordetella pertussis 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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