SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0350-081-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
CyFlow Counter System with CD4 easy count kit and CD4% easy count kit
Assay Type
Flow cytometry
IVD Public Report Category
CD4 technologies
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
Sysmex Partec GmbH
Arndtstrasse 11a-b
Goerlitz,
2826
Germany
Pathogen
HIV
Specimen Type
Whole blood (venous)
Product Code
Identification name
05-8410
Test kit package size
100
Test Package Size
CD4 easy count kit to count absolute CD4+ T-lymphocytes, Vial containing CD4 mAb PE and Bottle containing no lyse buffer
Identification name
05-8411
Test kit package size
100
Test Package Size
CD4% easy count kit to count absolute CD4+ T-lymphocytes and CD4 percentages, vial containing CD4 mAb PE, Vial containing CD45 mAb PE-Cy5, Bottle containing Buffer 1 and Bottle containing Buffer 2
Identification name
CY-S-3023
Identification name
05-8401
Test kit package size
100
Test Package Size
CD4 easy count kit to count absolute CD4+ T-lymphocytes, Vial containing CD4 mAb PE and Bottle containing no lyse buffer
Identification name
05-8405
Test kit package size
100
Test Package Size
CD4% easy count kit to count absolute CD4+ T-lymphocytes and CD4 percentages
IVD Manufacturing Site(s)
EXBIO Praha, a.s
Nad Safinou II 341
Vestec,
25250
Czechia