Identification of the person placing the product on the market
ABEL DEMEDICAL LTD
EIK
204849693
BG
SOF
Sofia
Elly Tchoubrieva
0884715946
office@abeldemedical.com
Identification of the wholesaler
ABEL DEMEDICAL LTD
EIK
204849693
BG
SOF
Sofia
Elly Tchoubrieva
0884715946
office@abeldemedical.com
IV-P-T/ МИ1451
14/12/2017
General medical information about the device
06 - In vitro diagnostic devices
Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTL
Various
GMDN
30830
Hepatitis B Virus Surface
Description of the medical device
1
Intended action by the manufacturer
Hepatitis B Virus Surface Antigen (HBsAg) Test is a rapid
immunochromatographic assay for the qualitative detection of HBsAg in human whole blood, serum or plasma samples at or above a level of 1 ng/ml. It is intended for professional use as an aid in the diagnosis of Hepatitis B virus.