8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
DG 3 D N. 1.5 V=100 STÜ Superior
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
DG 3 D N.1 V=100 STÜ Superior CE
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
DG 3 D N.0 V=100 STÜ Superior CE
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
DG 3 D N.3 V=50 STÜ Superior CE
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
HX 1170693-1
Certificate
IVDR QMS·DRG Instruments GmbH·TÜV Rheinland LGA Products GmbH
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 22, 2018
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·September 4, 2019
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
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 14, 2019