SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0085-028-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
careHPV Test
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HPV NAT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
QIAGEN GmBH
QIAGEN Strasse 1
Hilden,
40724
Germany
Pathogen
HPV
Specimen Type
Swab (cervicovaginal)
Product Code
Identification name
614015
Test kit package size
96
Test Package Size
614015 kit contains:
Assay Microplate: 1
Negative Calibrator: 0
Assay Microplate: 1
Negative Calibrator: 0
IVD Manufacturing Site(s)
Qiagen Shenzhen Co. Ltd
6&7/F, R3-B, High-tech Industrial Park
Shenzhen,
xxxx
China
Qiagen Germantown
19300 Germantown Road
Germantown, MD,
20874
United States of America