Dräger DrugTest 5000 STK IVD (Test-Kits)

Conforms to requirements of DIN EN ISO 13485:2016 / EN ISO 13485:2016, DIN EN ISO 11469:2000, DIN EN 13612:2002, DIN EN ISO 14971:2013, DIN EN ISO 15223-1:2013, DIN EN ISO 18113-1:2013, DIN EN ISO 18113-3:2013, DIN EN 60529:2000, DIN EN 61010-1:2011, DIN EN 61010-2-101:2003, DIN EN 61326-1:2013, DIN EN 61326-2-6:2013, DIN EN 62304:2007/AC:2009, DIN EN 62366:2008, Declaration 98/79/EC.

Conforms to requirements of the Technical Regulations for in vitro diagnostic medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 of 02.10.2013

The Dräger DrugTest 5000 STK IVD (Test-Kits) is intended for use as part of a testing system along with the analyzer of narcotic drugs and psychotropic substances in the oral fluid Dräger DrugTest 5000 Analyzer IVD for the simultaneous detection of narcotic drugs in the oral fluid (saliva) of a person substances of the following groups: opiates, cannabinoids, cocaine, amphetamine, methamphetamine, benzodiazepines for the purpose of qualitative diagnosis (in vitro). With the help of the Dräger DrugTest 5000 STK IVD (Test-Kits), a simple non-invasive and hygienic procedure for sampling saliva is carried out, its design provides for monitoring the selection of the required volume of saliva samples, as well as the interaction between the breakdown of saliva and the reagents applied to the test strips located inside the test cassette from the Dräger DrugTest 5000 STK IVD (Test-Kits).

 

Dimensions (WxHxD): 150x38x80 mm. Weight: 45 g. Storage / transportation: from +4 to +30 ° C.

Designation	Drug (Substances)	Calibrator Analytical Cut-Off (ng/ml)
AMP	Amphetamine (D-Amphetamine)	50
BZO	Diazepam	15
COC	Cocaine (Cocaine)	20
MET	Methamphetamine (D-methamphetamine)	35
MTD	Methadone (Methadone)	20
KET	Ketamin (Ketamin)	300
OPI	Opiates (Morphine)	20
THC	Tetrahydrocannabinol (Δ9-THC)	5