Duns Number:202672846
Device Description: The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women..
Catalog Number
130932
Brand Name
GenePOC™ GBS LB
Version/Model Number
130932
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2021
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
1be72080-16be-43d0-88a0-c2c48461f551
Public Version Date
October 01, 2021
Public Version Number
4
DI Record Publish Date
December 29, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |