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Hepatitis B Virus Surface Antigen (HBsAg) test

Max. value paid with public resources: Processing

Data for med. device
06А2V3083002745
02/10/2018 11:15
02/10/2018 11:27
27/09/2018 14:05
Identification of the manufacturer
Artron Laboratories Inc.
Other
00000
00000
CA
Burnaby, BC
V5J 5H6
Marcus Lum
+1(604)415-9757 ext. 116
marcus@artronbio.com
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 Antigen (HBsAg) test
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.
Single use
A02-01-222
General trade information
Processing
2018-IVD/DE-005
25/08/2023