Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
US Nationwide distribution in the states of CA, KY.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2020