14 results
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14ms
·
Sources: EU EUDAMED, US FDA
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 13, 2017
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·March 7, 2018
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·March 7, 2018
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·March 7, 2018
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·March 7, 2018
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Enforcement
Class II
·Terminated·DRG International, Inc.·April 13, 2022
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