Device product
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
Z-2159-2019
Product summary
- Event
- Event 83183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 kits
- Official record key
device-enforcement:Z-2159-2019
Official wording
Reason: 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
Code information: Lot Numbers: 66K118, 66K019
Distribution pattern: Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Derived failure modes
-
Unknown
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