SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0106-038-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
DS-EIA-HIV-AGAB-SCREEN
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HIV 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
HIV
Specimen Type
Plasma
Serum
Product Code
Identification name
I-1652/1.2
Test kit package size
192
Test Package Size
Kits: I-1654/I-1652/I-1656
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
Identification name
I-1654/1.2
Test kit package size
96
Test Package Size
Kits: I-1654/I-1652/I-1656
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
Identification name
I-1656/1.2
Test kit package size
480
Test Package Size
Kits: I-1654/I-1652/I-1656
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
HIV AG/AB Coated Strips: 96 tests, 1 plate/192 tests, 2 plates/480 tests, 5 plates
Conjugate-1 (concentrated 11-fold): 1 vial of 1
IVD Manufacturing Site(s)
AB Diagnostic Systems GmbH
Sportfliegerstrasse 4
Berlin,
12487
Germany