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

Name: Molecular Reagent
Brand: Xpert®

REAGENT, IVD XPERT GBS LB XC MOD-COMPLEX (10T/KIT) D/S

McKesson #

1224763

Manufacturer #

GXGBSLBXC-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

Other Infectious Disease

Test Format

Cartridge

Test Method

Real-Time RT-PCR

Test Name

Group B Streptococcus (GBS) LB XC

Test Type

Molecular Diagnostic

Time to Results

43 Minute Time to First Result

UNSPSC Code

41116029

The Xpert GBS LB XC test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using real-time polymerase chain reaction (PCR)
Xpert GBS LB XC testing is indicated as an aid in determining the GBS colonization status of antepartum women
Molecular diagnostic test for qualitative detection of Group B Streptococcus (GBS) using enriched Lim broth cultures of patient samples
Moderate complexity
Accurate antepartum GBS testing is critical in the prevention of neonatal GBS infections