Printer Friendly

TECHLAB passes US FDA 510(k) clearance to market campylobacter tests for the diagnosis of campylobacteriosis bacteria.

M2 EQUITYBITES-January 24, 2018-TECHLAB passes US FDA 510(k) clearance to market campylobacter tests for the diagnosis of campylobacteriosis bacteria

(C)2018 M2 COMMUNICATIONS http://www.m2.com

Diagnostic company TECHLAB Inc reported on Tuesday the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for the CAMPYLOBACTER QUIK CHEK and the CAMPYLOBACTER CHEK tests for the diagnosis of campylobacteriosis in the US.

Campylobacter is a foodborne pathogen and is estimated to affect more than 1.3m people annually in the US and campylobacteriosis is the most common cause of diarrheal illness in the US.

The company's CAMPYLOBACTER QUIK CHEK test is a rapid diagnostic test that detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes. The CAMPYLOBACTER CHEK test is a 96-well plate format for laboratories testing large numbers of specimens and can be used with or without automation.

According to the company, the CAMPYLOBACTER CHEK and CAMPYLOBACTER QUIK CHEK tests have accuracies that surpass culture and have the highest positive predictive values (PPV) among currently available Campylobacter immunoassays.

The CAMPYLOBACTER QUIK CHEK and CAMPYLOBACTER CHEK tests offer quick and reliable detection of Campylobacter-specific antigen in human fecal specimens, concluded the company.

((Comments on this story may be sent to info@m2.com))

COPYRIGHT 2018 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2018 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Date:Jan 24, 2018
Words:210
Previous Article:United Financial Bancorp reports reduced net income for Q4 2017 over Q4 2016.
Next Article:TechCare to market Novokid lice treatment device in the Netherlands via MWMedical BV.
Topics:

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters