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0120-038-00

SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0120-038-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
DS-EIA-HBsAg-0,01, ENZYME IMMUNOASSAY FOR DETECTION AND CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HBV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
RPC Diagnostic Systems, Ltd.
22 Yablonevaya
Nizhniy Novgorod,
603093
Russian Federation
Pathogen
HBV
Specimen Type
Plasma
Serum
Whole blood (venous)
Product Code
Identification name
B-1252/1.2
Test kit package size
192
Test Package Size
Kits contain:
Anti-HBsAg Coated Strips
Conjugate-1 (concentrated 11-fold)
Conjugate-2 (concentrated 11-fold)
Conjugate-1 diluent
Conjugate-2 diluent
Positive Control Inactivated
Low Positive Control lyophilized, Inactivated
Negative Control Inactivated
Washing Solution (concentrated 25-fold)
Substrate Buffer
TMB (concentrated 16-fold)
Stopping Reagent
HBs Ag Confirmatory reagent Inactivated
Control reagent Inactivated
Identification name
B-1254/1.2
Test kit package size
96
Test Package Size
Kits contain:
Anti-HBsAg Coated Strips
Conjugate-1 (concentrated 11-fold)
Conjugate-2 (concentrated 11-fold)
Conjugate-1 diluent
Conjugate-2 diluent
Positive Control Inactivated
Low Positive Control lyophilized, Inactivated
Negative Control Inactivated
Washing Solution (concentrated 25-fold)
Substrate Buffer
TMB (concentrated 16-fold)
Stopping Reagent
HBs Ag Confirmatory reagent Inactivated
Control reagent Inactivated
Identification name
B-1255/1.2
Test kit package size
480
Test Package Size
Kits contain:
Anti-HBsAg Coated Strips
Conjugate-1 (concentrated 11-fold)
Conjugate-2 (concentrated 11-fold)
Conjugate-1 diluent
Conjugate-2 diluent
Positive Control Inactivated
Low Positive Control lyophilized, Inactivated
Negative Control Inactivated
Washing Solution (concentrated 25-fold)
Substrate Buffer
TMB (concentrated 16-fold)
Stopping Reagent
HBs Ag Confirmatory reagent Inactivated
Control reagent Inactivated
Identification name
B-1256/1.2
Test kit package size
96
Test Package Size
Kits contain:
Anti-HBsAg Coated Strips
Conjugate-1 (concentrated 11-fold)
Conjugate-2 (concentrated 11-fold)
Conjugate-1 diluent
Conjugate-2 diluent
Positive Control Inactivated
Low Positive Control lyophilized, Inactivated
Negative Control Inactivated
Washing Solution (concentrated 25-fold)
Substrate Buffer
TMB (concentrated 16-fold)
Stopping Reagent
HBs Ag Confirmatory reagent Inactivated
Control reagent Inactivated
Identification name
B-231/1.2
Test kit package size
200
Test Package Size
Kits contain:
Anti-HBsAg Coated Strips
Conjugate-1 (concentrated 11-fold)
Conjugate-2 (concentrated 11-fold)
Conjugate-1 diluent
Conjugate-2 diluent
Positive Control Inactivated
Low Positive Control lyophilized, Inactivated
Negative Control Inactivated
Washing Solution (concentrated 25-fold)
Substrate Buffer
TMB (concentrated 16-fold)
Stopping Reagent
HBs Ag Confirmatory reagent Inactivated
Control reagent Inactivated
IVD Manufacturing Site(s)
AB Diagnostic Systems GmbH
Sportfliegerstrasse 4
Berlin,
12487
Germany