illumigene Group B Streptococcus 280350

GUDID 00840733101342

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.

MERIDIAN BIOSCIENCE, INC.

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840733101342
NIH Device Record Keyc8a9ab2f-c318-4c02-963a-6d1ed0f9c5ca
Commercial Distribution StatusIn Commercial Distribution
Brand Nameillumigene Group B Streptococcus
Version Model Number280350
Catalog Number280350
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

Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101342 [Primary]

FDA Product Code

NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

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

Devices Manufactured by MERIDIAN BIOSCIENCE, INC.

00840733103025 - Para-Pak Modified (Cu) PVA2023-10-25 Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination
00840733101472 - Premier HpSA Flex2023-09-05 The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori ant
00840733101410 - Meridian Viral Transport2023-08-15 Meridian Viral Transport is a system which contains all materials necessary to collect and transport clinical specimens for vira
00840733103308 - Curian Shiga Toxin 2023-06-05 The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simulta
00840733102387 - Curian Campy2023-03-31 Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campyloba
00840733103285 - Revogene Check2022-07-05 The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm th
00840733102844 - Para-Pak SAF2022-04-01 The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool speci
00840733101434 - BreathTek UBT for H. pylori 2022-02-21 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated wi
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.