FDA-Device2018-08-22Class II
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Hazard
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Sold states
NJ; Germany, Belgium, Spain & Germany
Affected count
169 kits
Manufactured in
Frauenbergstr. 18, Marburg, Germany
Products
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2836-2018Don't want to check this manually?
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