DRG Instruments GmbH

FDA Regulatory Profile

DRG Instruments GmbH appears in FDA public data with 3 recalls, 0 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2410-2019, Class II) was initiated on June 6, 2019.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2410-2019Class IIDRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: June 6, 2019
Z-2159-2019Class IIDRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3May 21, 2019
Z-2836-2018Class IISalivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free EJuly 14, 2016