FDA gives 510(k) approval for Shiga Toxin Direct Test for Shiga toxin-producing E. coli- Great Basin Scientific
Great Basin Scientific announced that the FDA has granted 510(k) clearance for its Shiga Toxin Direct Test. The Company provides the only FDA-cleared stand-alone molecular test to detect Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen.
The Shiga Toxin Direct Test can be run on the Great Basin Analyzer, which also performs Great Basin’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS), as well as the Company’s multi-plex Staph ID/R Blood Culture Panel, which is pending 510(k) clearance from the FDA.
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