FDA.reportPublic FDA data

illumigene Group B Streptococcus

Primary DI
00840733101342
Brand
illumigene Group B Streptococcus
Company
MERIDIAN BIOSCIENCE, INC.
Model
280350
Catalog number
280350
Device description
The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.
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
00840733101342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101342008407331013428407331013420840733101342

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius27 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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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
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07332940004545SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004569SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004583SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004606SmartCycler Dx SystemCEPHEIDNJR2018-07-03
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