#1151944
Meridian #410200

Sexual Health Test Kit Revogene® GBS LB Strep B Test (LIM Broth Enriched) 24 Tests CLIA Non-Waived

Name: Sexual Health Test Kit
Brand: Revogene® GBS LB

TEST KIT, F/GBC LIM BROTH (24/BX)

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Product Specifications

McKesson #

1151944

Manufacturer #

410200

Brand

Revogene® GBS LB

Manufacturer

Meridian

Country of Origin

Canada

Application

Sexual Health Test Kit

CLIA Classification

CLIA Moderate Complexity

CLIA Classified

CLIA Non-Waived

Contents 1

(24) Individual Pouches each containing Disposable Transfer Tool, Carba Sample Buffer Tube, and Carba Microfluidic Cartridge (PIE)

For Use With

For Revogene® Molecular Platform

Number of Tests

24 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 60 days

Purchase Program Type

Standard Purchase

Reading Type

Machine Read

Sample Type

Rectal Swab / Vaginal Secretion Sample

Specialty

Molecular

Technology

Real-time PCR Technology

Test Format

Cartridge Format

Test Kit Type

Rapid

Test Name

Strep B Test (LIM Broth Enriched)

Test Type

Molecular Diagnostic

Time to Results

70 Minute Results

UNSPSC Code

41116129

Features

The GenePOC™ GBS LB assay performed on the revogeneTM instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women
The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome
The GBS LB assay can provide results from up to eight specimens in approximately one hour once the LIM broth culture sample is available
The assay minimizes operator intervention from the time the single-use disposable microfluidic cartridge (PIE) containing the sample is placed into the revogene carousel until results are available