Medical Products
-
Covid-19 Test Kits
-
Medical Devices & Diagnostic Machines
-
In Vitro Diagnostics
-
Health Products
​
Please contact us for further information.
Covid-19 Test Kits
COMBO4
RSV+INFLUENZA A/B+COVID-19
COMBO AG TEST
CorDx RSV+Influenza A/B+Covid-19 Combo Ag test for the swab in the anterior nasal area offers the opportunity to quickly and easily get certainty within 15 minutes
​
What can RSV+Influenza A/B+COVID-19 Combo Ag Tests?
-
Test result within 15 minutes
-
4 results with just one test
-
FLU A antigen detection: 99.43%*
-
FLU B antigen detection: 99.15%*
-
RSV antigen detection: 99.14%*
-
COVID-19 antigen detection: 97.86%*
-
Swab in the anterior nasal area
-
Pre-filled buffer solution
-
CE marked
-
1 and 5 packages
*Clinical Evaluation Report for COVID-19 Ag in Influenza A/
B+COVID-19/RSV Combo Ag Test by CorDx, Inc; 04/204.2022
​
​
​
​
JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit
(Colloidal Gold)
Rapid test for the detection of viral SARS-CoV-2 nucleoprotein antigens by anterior-nasal (short nose), oropharyngeal and nasopharyngeal smear.
​
Inclusion in Pack
-
1 x pack with 20 pieces test cards,
-
20 individual buffer solutions,
-
20 extraction tubes
-
20 sterile swabs for the short-nose swab AND 20 sterile swabs for the normal nose and throat swab
​
Production Standards
EN ISO 13485:2016, EN ISO 14971:2012
EN ISO 15223-1:2016, N ISO 18113-1:2011
EN ISO 18113-2:2011, EN ISO 23640:2016
EN 13975:2003, EN 13612:2002
​
Download Letter of declaration
Download EC Declaration of Conformity
SEJOY SARS-CoV-2 Antigen Rapid Self-Test Kit
Rapid Self-test for the detection of viral SARS-CoV-2 nucleoprotein antigens by anterior-nasal
​
Inclusion in Pack
-
Single pack with 1 piece test card
-
1 individual buffer solution
-
1 extraction tube
-
1 sterile swab for the short-nose swab
-
1 Biohazard waste bag
-
1 IFU (Instructions for Use)
-
1 Certificate of Manufacture
​
Production Standards
EN ISO 13485:2016; EN ISO 14971:2012;
EN 13532:2002; EN ISO 23640:2015;
EN ISO 13612:2002; EN ISO 17511:2003;
EN 13975:2003; EN ISO 18113-1:2011;
EN ISO 18113-4:2011; EN ISO 15223-1:2016;
EN 13641:2002; EN 62366:2008
​
Medical Devices & Diagnostic Machines
GETEIN 1100 POCT Fluorescence Immunoassay
Analyzer (with WiFi)
Getein1100 is used to measure the concentration of biomarkers in human whole blood, serum, plasma or urine samples. The results can be used as an aid in the clinical diagnosis of laboratory and POCT-optimized point-of-care tests.
​
Inclusion with Machine
-
Power cable and transformer
-
USB2.0 – RS232 computer interface cable
-
USB flash disc
-
Instruction manual
​
Applicable Standards
EN ISO 13485:2016; EN ISO 14971:2012; EN ISO
23640:2015; EN ISO 13612:2002; EN ISO 18113-
1:2011; EN ISO 18113-2:2011; EN ISO 18113-3:2011; EN ISO 15223-1:2016; ISO 780:2015; EN 61326-2-6:2006; EN 61326-1:2013; EN 61010-2-101:2002; EN 61010-1:2010
​
Download Analyzer Presentation
Download Antibody Fast Testkit Description
MAVERICK MQ4164 - POCT Quantitative PCR system
Maverick is a portable, high performance real time quantitative PCR system and is equipped with a
4-channel fluorescence optical system powered by an ultra-low-light CMOS bio-imaging sensor. It
is optimally suited for applications where portability, minimal space, fast time-to-result (40
minutes) is required. Applications are: Point-of-Care molecular diagnostics tests (POCT).
​
Inclusion with Machine
-
Maverick MQ4164 qPCR machine
-
Power cable and transformer
-
USB2.0 – RS232 computer interface cable
-
USB flash disc with software
-
Instruction manual
​
Applicable Standards
EN ISO 13485:2016, EN ISO 18113-3:2011,
EN 13612:2002, EN ISO 14971:2012, EN 13641:2002, EN ISO 23640:2015, EN ISO 18113-1:2011, EN ISO 15223-1:2016, EN 62366-1:2008, EN ISO 18113-2:2011, Directive 98/79/EC of the European Parliament and of the Council on In-Vitro Diagnostic Medical Devices.
​
Download RT-PCR Short Brochure