Duns Number:092815364
Device Description: The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qual 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.
Catalog Number
280350
Brand Name
illumigene Group B Streptococcus
Version/Model Number
280350
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJR
Product Code Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Public Device Record Key
c8a9ab2f-c318-4c02-963a-6d1ed0f9c5ca
Public Version Date
July 16, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |