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.
DRG Instruments GmbH
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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