10 results
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71ms
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Sources: EU EUDAMED, US FDA
CURE POINT THERAPEUTICS, INC
FDA registration
CURE POINT THERAPEUTICS, INC·2 products·🇺🇸 United States
Dimed
FDA UDI
CURE POINT THERAPEUTICS, INC.·00860014872211·Fiber Optic Cable: Attaches to Class 4 - Sirona...
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
FDA Recall
Terminated
·Alere San Diego dba Biosite Innovacon Hemosense Inc·Product code DJR·March 12, 2010
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers