Ansh Labs, LLC

1 FDA 510(k) medical device clearance, cleared in 2018, with 1 FDA device recall on record.

FDA recalls by Ansh Labs, LLC

Z-0842-2021 — AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.Class II·Terminated·2020-12-18

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Ansh Labs, LLC

DEN180004 — picoAMH ELISACode QDH·2018-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Ansh Labs, LLC

FDA recalls by Ansh Labs, LLC

Recent clearances by Ansh Labs, LLC