Research Use Only/Microbiology

FDA product code OTT · Not classified · Microbiology

For research use only and for products imported into the US only.

0510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules

Recalls

RecallProductFirmInitiated
Z-0238-2016 Class IIFocus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro…Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase… Focus Diagnostics Inc10/02/2015Terminated