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#1021224763 | Mfg #GXGBSLBXC-10 | Clinical Laboratory

Sexual Health Reagent Xpert® Molecular Diagnostic Group B Streptococcus (GBS) LB XC For use with GeneXpert Instrument System 10 Tests

REAGENT, IVD XPERT EV 10 D/S
Sexual Health Reagent Xpert® Molecular Diagnostic Group B Streptococcus (GBS) LB XC For use with GeneXpert Instrument System 10 Tests

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)

Product Specifications

MSFH #
1021224763
Manufacturer #
GXGBSLBXC-10
Brand
Xpert®
Manufacturer
Cepheid
Country of Origin
Unknown
Application
Sexual Health Reagent
CLIA Classification
CLIA Non-Waived
Container Type
Cartridge
For Use With
For use with GeneXpert Instrument System
Number of Tests
10 Tests
Sample Type
Vaginal / Rectal Swab Sample
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 Results
UNSPSC Code
41116029

Description

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

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