#1251995
Cepheid #XPRSGBS-10

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

REAGENT, IVD XPERT GBS MOD-COMPLEX (10/KT) D/S

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

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

Product Specifications

McKesson #

1251995

Manufacturer #

XPRSGBS-10

Brand

Xpert® Xpress

Manufacturer

Cepheid

Country of Origin

Unknown

Application

Molecular Reagent

Buy American Act (BAA) Compliant

No

CLIA Classification

CLIA Moderate Complexity

CLIA Classified

CLIA Non-Waived

For Use With

For GeneXpert Instrument Systems

Number of Tests

10 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Sample Type

Rectal / Vaginal Swab Sample

Specialty

Molecular

Test Category

Other Infectious Disease

Test Format

Cartridge

Test Name

Group B Streptococcus (GBS)

Test Type

Real-time PCR

Time to Results

30 Minute Results

Trade Agreement Act (TAA) Compliant

No

UNSPSC Code

41116029

Volume

R1: 3 mL, R2: 1.5 mL

Features

The Xpert® Xpress GBS test, performed on the GeneXpert Instrument Systems is an automated qualitative in vitro diagnostic test for the detection of DNA from Group B Streptococcus (GBS) using real-time polymerase chain reaction (PCR)
The test is performed using a dual vaginal/rectal swab specimen collected from pregnant females during antepartum or intrapartum
Identify GBS colonisation status at the time of labor
Reduce unnecessary use of intrapartum antibiotic prophylaxis (IAP)