SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
09308-027-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Alinity m HR HPV
Assay Type
NAT - PCR
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
Abbott Molecular Inc.
1300 East Touhy Avenue
Des Plaines,
60018
United States of America
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
09N15-090
Test kit package size
384
Identification name
09N15-080