FDA-Device2019-08-14Class II
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
DRG Instruments GmbH
Hazard
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
Sold states
Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Affected count
38 kits
Manufactured in
Frauenbergstr. 18, N/A, Marburg, N/A, Germany
Products
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2019Don't want to check this manually?
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