SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0454-140-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Accupower HIV-1 Quantitative RT-PCR
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV NAT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Bioneer Corporation
Bioneer Global Center, 71, Techno 2-ro,
Yuseong-gu, Daejeon,
Daejeon-gwangyeoksi
34013
Republic of Korea
Pathogen
HIV
Specimen Type
Plasma
Product Code
Identification name
HIV-1111 (ROW version)
Test Package Size
premixed qPCR tubes
standard positive control
low positive control
high positive control
non-template control
buffer
optical sealing film
package insert (quick manual)
Other boxes/reagents
K-4471 ExiPrep Dx Viral DNA/RNA kit 96 tests/kit
K-4473 Exiprep Dx Viral RNA Kit 96 tests/kit
KA-3011 RNA IPC sample loading tube 96 tests/kit
standard positive control
low positive control
high positive control
non-template control
buffer
optical sealing film
package insert (quick manual)
Other boxes/reagents
K-4471 ExiPrep Dx Viral DNA/RNA kit 96 tests/kit
K-4473 Exiprep Dx Viral RNA Kit 96 tests/kit
KA-3011 RNA IPC sample loading tube 96 tests/kit