SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0156-053-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Aquios CL flow cytometer
Assay Type
Flow cytometry
IVD Public Report Category
CD4 technologies
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Beckman Coulter Life Sciences(Blue Ocean Biomedical LLC)
1 SW 129th Ave, Suite 201, FL
Pembroke Pines,
33027
United States of America
Pathogen
HIV
Specimen Type
Whole blood (venous)
Product Code
Identification name
B23502
Identification name
B23533
Identification name
B23534
Identification name
B23535
Identification name
B23536
Identification name
B23538
Identification name
B25697
Identification name
B25698
Identification name
B25700
Identification name
B30166
Identification name
B39101
Identification name
B39102
IVD Manufacturing Site(s)
Beckman Coulther Life Sciences - reagents
740 W 83 Street
Hialeah, Florida,
United States of America