FDA.reportPublic FDA data

illumigene Group B Streptococcus External Control Kit

Primary DI
00840733101311
Brand
illumigene Group B Streptococcus External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
279900
Catalog number
279900
Device description
The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. 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
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101311008407331013118407331013110840733101311

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group B Streptococcus 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 Group B beta-haemolytic Streptococcus 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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00840733101717PREMIER CAMPY6180966180962020-09-01
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00840733102585Hemo-De8013008013002020-12-09
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00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940008161GeneXpert®CEPHEIDNJR2024-02-16
06974849369243Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369250Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369267Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369274Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369281Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPJiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
07332940007652Xpert®CEPHEIDNJR2022-07-29
07332940007669Xpert®CEPHEIDNJR2022-07-29
07332940007683GeneXpert®CEPHEIDNJR2022-05-03
07332940007690GeneXpert®CEPHEIDNJR2022-05-03
00840733102363Revogene GBS LBMERIDIAN BIOSCIENCE, INC.NJR2020-07-15
00628055344117Revogene® GBS LBMeridian Bioscience Canada IncNJR2019-10-21
15420045510470Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510890Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510463Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510906Panther Fusion®Hologic, Inc.NJR2019-07-30
10814278020045NeuMoDxTM GBS Test StripNeumodx Molecular, Inc.NJR2019-04-03
30014613336440SolanaDIAGNOSTIC HYBRIDS, INC.NJR2019-03-21
00840733102110Alethia™ Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
00840733102196Alethia™ Group B StreptococcusMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
20816101025644Simplexa™ GBS DirectDIASORIN MOLECULAR LLCNJR2018-11-20
20816101025651Simplexa™ GBS Positive Control PackDIASORIN MOLECULAR LLCNJR2018-11-20
30014613312024AmpliVueQUIDEL CORPORATIONNJR2018-08-30
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07332940004538SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004545SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004569SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004583SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004606SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004767SmartCycler Dx SystemCEPHEIDNJR2018-07-03