Woman Health / Vaginitis Infections Panel MAXI Kit
REF VSNWHV00225/50/100 rxnIVDR Application Active
Woman Health / Vaginitis Infections Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Woman Health / Vaginitis Infections MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation. Woman Health / Vaginitis Infections Panel MAXI Kit is listed under REF VSNWHV002 in the LDT-Type PCR Test Kits portfolio. The catalog pack or reaction format is 25/50/100 rxn. Catalog note: Eight-tube expanded women’s health 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
Woman Health / Vaginitis Infections Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Woman Health / Vaginitis Infections MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation.
Target analyte / scope
Woman Health / Vaginitis Infections MAXI
Method / technology
Multiplex Real-Time PCR
Pack / reactions
25/50/100 rxn
Internal control present
Yes
Catalog description
Eight-tube expanded women’s health panel.
Kit components
Tube 1: H. ducreyi · BVAB-2 · Fannyhessea vaginae · RNase P; Tube 2: C. albicans · C. glabrata · C. parapsilosis · B. fragilis; Tube 3: E. coli · S. agalactiae · Prevotella bivia · Atopobium vaginae; Tube 4: L. gasseri · L. iners · L. crispatus · CMV; Tube 5: T. pallidum · MP-1 · MP-2 · C. krusei; Tube 6: M. curtisii · M. mulieris · S. aureus · U. parvum/urealyticum; Tube 7: HSV-1/2 · T. vaginalis · L. jensenii · E. faecalis; Tube 8: C. tropicalis · G. vaginalis · M. genitalium · B. atrophaeus
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.
