Molecular Reagent Xpert® Group B Strep (GBS) LB CLIA Non-Waived For GeneXpert Systems 10 Tests

Name: Molecular Reagent
Brand: Xpert®

REAGENT, IVD XPERT GBS LB N/S TRL LF ROOM TEMP (10TEST/KT)

McKesson #

1236776

Manufacturer #

GXGBS-LB-10

Brand

Xpert®

Manufacturer

Cepheid

Country of Origin

Unknown

Application

Molecular Reagent

CLIA Classification

CLIA Non-Waived

CLIA Classified

CLIA Non-Waived

For Use With

For GeneXpert Systems

Number of Tests

10 Tests

Sample Type

Rectal / Vaginal Swab Sample

Specialty

Molecular

Test Category

Sexual Health

Test Format

Cartridge

Test Method

NAAT

Test Name

Group B Strep (GBS) LB

Test Type

Real Time RT-PCR

Time to Results

35 Minute Results

UNSPSC Code

41116130

Volume

R1: 3 mL, R2: 3 mL

The Cepheid Xpert GBS LB Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using fully automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA
Delivers results on positive Lim broth samples in 35 minutes
Fast accurate NAAT results
Used for Antepartum testing on enriched lim broth cultures of vaginal/rectal swabs