— LDT-Type PCR Test Kits

HPV Full Genotyping Kit

REF VSNP004-G25/50/100 rxnIVDR Application Active

HPV Full Genotyping Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying HPV Full as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation. HPV Full Genotyping Kit is listed under REF VSNP004-G in the LDT-Type PCR Test Kits portfolio. The catalog pack or reaction format is 25/50/100 rxn. Catalog note: Eight-tube comprehensive HPV genotyping panel. Confirm the current product-specific IFU, regulatory status and country availability before ordering or clinical use.

Verified catalog information

Product family
LDT-Type PCR Test Kits
Intended use
HPV Full Genotyping Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying HPV Full as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation.
Target analyte / scope
HPV Full
Method / technology
Multiplex Real-Time PCR
Pack / reactions
25/50/100 rxn
Catalog description
Eight-tube comprehensive HPV genotyping panel.
Kit components
Tube 1: HPV 16 · HPV 18 · HPV 31 · RP; Tube 2: HPV 56 · HPV 58 · HPV 51 · HPV 54; Tube 3: HPV 45 · HPV 35 · HPV 59 · HPV 53; Tube 4: HPV 68 · HPV 39 · HPV 66 · HPV 82; Tube 5: HPV 33 · HPV 52 · HPV 61 · HPV 62/67; Tube 6: HPV 6/11 · HPV 42 · HPV 70 · HPV 26; Tube 7: HPV 90/91 · HPV 43 · HPV 81 · HPV 71; Tube 8: HPV 40 · HPV 44 · HPV 69 · HPV 74
Regulatory status
Formal IVDR application received and written agreement concluded with GMED SAS (Notified Body 0459). This status is not an IVDR certificate or certification claim. Class C transitional timeline: 31 December 2028, subject to continued compliance with Article 110.3c conditions.
IFU / technical documentsQuotation / distributor informationRequest private label manufacturingClinical performanceTechnical support

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