Great Basin Group B Streptococcus Test

Primary DI

D-888501395GBGBSKH

Basic UDI-DI Code

B-888501395GBGBSKH

Reference

300781

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Great Basin GBS Assay, performed on the Great Basin PA500 Analyzer System, is a qualitative in vitro diagnostic test (IVD) for the detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women, following enrichment in LIM Broth for 18 - 29 hours. The assay utilizes automated sample preparation and polymerase chain reaction (PCR) to amplify a cfb gene sequence specific to the Streptococcus agalactiae (GBS) genome which is detected by hybridization probes immobilized on a silica chip surface. Results from the GBS Assay can be used as an aid in determining colonization status in antepartum women. The GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The GBS Assay is intended for use in clinical laboratory, hospital laboratory, and reference laboratory settings. The GBS Assay is not intended for point of care use.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).