Biomeme, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0452-2022Class IIBiomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 SubcomponentOctober 20, 2021
Z-0940-2021Class IIINucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoJanuary 5, 2021
Z-0513-2021Class IIThe Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based oOctober 23, 2020