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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


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.

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Publication:M2 EquityBites (EQB)
Date:Jan 24, 2018
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