FDA-Device2019-09-04Class II
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
DRG Instruments GmbH
Hazard
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
Sold states
Distribution to Canada
Affected count
8 Kits
Manufactured in
Frauenbergstr. 18, N/A, Marburg, N/A, Germany
Products
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2019Don't want to check this manually?
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