Home / Medical devices / COVID-19 IgG/IgM Rapid Tests Cassette

COVID-19 IgG/IgM Rapid Tests Cassette

Max. value paid with public resources: Processing

Data for med. device
06DV4044383763
GTIN
40443
31/03/2020 08:48
31/03/2020 09:54
30/03/2020 10:51
Identification of the manufacturer
Healgen Scientific Limited Liability Company
Other
ISO 13485:2016
SX 60135029 0001
US
Houston
Vincent Yi
+86 13567161959
vincent.yi@orientgene.com
Identification of the person placing the product on the market
Dans Pharma Ltd
EIK
130868975
BG
SOF
Sofia
1202
Boris Gorov
0882213518
sales1@danspharma.com
Identification of the wholesaler
Dans Pharma Ltd
EIK
130868975
BG
SOF
Sofia
1202
Boris Gorov
0882213518
sales1@danspharma.com
IV-P-T/МИ-764
23/11/2011
General medical information about the device
06 - In vitro diagnostic devices
IVD others
Various
GMDN
40443
COVID-19 IgG/IgM Rapid Tests Cassette
Intended action by the manufacturer
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
2-30°C
Single use
GCCOV-402a
General trade information
Processing