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Tag Archives: Techlab—

Techlab gets FDA clearance for H. pylori tests

Aug. 22, 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens. The H. Pylori Quik Chek test is a rapid diagnostic test that detects H. pylori in 30 minutes. The H. Pylori Chek test is a 96-well plate ...

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Triple parasite screen, 10/17

October 2017—TechLab received FDA clearance for the Tri-Combo Parasite Screen test. The test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp., and/or E. histolytica antigen in human fecal specimens. It specifically detects pathogenic E. histolytica and does not cross-react with nonpathogenic E. dispar.

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