Conforms to requirements of DIN EN ISO 13485:2016 / EN ISO 13485:2016, DIN EN 13612:2002, DIN EN 13641:2002, DIN EN 13975:2003, DIN EN ISO 14971:2013, DIN EN ISO 15223-1:2013, DIN EN ISO 18113-1:2013, DIN EN ISO 18113-2:2013, DIN EN ISO 23640:2015, DIN EN 62366:2008, DIN EN ISO 10993-1:2010, DIN EN ISO 10993-5:2009, DIN EN ISO 11469:2000, 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 Analyzer IVD analyzes the narcotic drugs and psychotropic substances in the oral liquid from the 5 to 8 most common classes of substances based on the analysis of saliva, that is, without the use of invasive methods. These devices are unique because they allow the on-site test to be performed automatically without human exposure and transmit the result promptly, within 10 minutes, without the usual blood test, the result on the printer or computer. The devices are implemented in traffic inspectorates and narcology services of all leading countries of the world, in labor protection and safety services in a number of Ukrainian enterprises.
Drug Testing System components include:
Dräger DrugTest 5000 STK IVD (Test-Kits): a ready-to-use test cassette with a built-in sample collector and volume adequacy indicator.
DrugTest 5000 Analyzer IVD: a rechargeable, fully automated analyzer providing controlled accurate analysis on site.
The system quickly and accurately checks samples of saliva for narcotics, amphetamines, synthetic amphetamines, opiates, cocaine and metabolites, benzodiazepines and cannabinoids, and also provides accurate diagnostic evaluation and data management.
The robust and easy-to-use Dräger DrugTest 5000 Analyzer IVD is a mobile optoelectronic system for local quality measurements of drugs in saliva samples collected with the Dräger DrugTest 5000 STK IVD (Test-Kits). Using a simple three-button control and a colored backlit display, users can view all interface menus in one of five languages. The built-in memory of the analyzer data can store the results of 500 measurements. In addition, the analyzer simply connects to various data logging devices - PCs, printers, or barcode scanners.
For analysis on the presence in the human body from 5 to 8 classes (depending on the type of test kit) of drugs and psychotropic substances in the oral fluid based on the analysis of saliva.
storage temperature from -20 ° C to + 60 ° C;
operating temperature from + 5 ° Ñ to + 40 ° Ñ;
relative humidity from 5 to 95%;
the ability to print test results on the printer Dräger Mobile Printer;
internal memory of 500 measurements;
dimensions (LxHxW) 200x250x220 mm;
power supply: built-in rechargeable battery or from an external network of 12 V DC (11-15V DC, completed with 220V AC adapter);
weight 4.5 kg;
relative humidity from 5 to 95%;
interfaces: Optical IRDA (printer), PS / 2, USB Slave.
Depending on the Dräger DrugTest® 5000 STK IVDconfiguration, the Dräger DrugTest® 5000 system can detect up to eight classes of narcotic drugs and psychotropic substances in the oral fluid with predetermined detection limits:
Calibrator Analytical Cut-Off (ng/ml)
The following order specifications are possible:
Dräger DrugTest® 5000 STK Training Test Kit IVD (Test Kits),
Dräger DrugTest® 5000 STK 5 IVD (Test-Kits) COC-OPI-THC-AMP-MET,
Dräger DrugTest® 5000 STK 6 IVD (Test-Kits) COC-OPI-BZO-THC-AMP-MET,
Dräger DrugTest® 5000 STK 7 IVD (Test-Kits) COC-OPI-BZO-THC-AMP-MET-MTD,
Dräger DrugTest® 5000 STK 8 IVD (Test-Kits) COC-OPI-BZO-THC-AMP-MET-MTD-KET.
Test kits are packaged in 20 pieces.
Device for collecting samples of oral fluid Drager DCD 5000,
Sampler for surfaces of Dräger SSK 5000 Test Kit.
How does the Dräger DrugTest 5000 Analyzer IVD works ? Overview
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