Urinary Tract Infections Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Urinary Tract Infections MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation. Urinary Tract Infections Panel MAXI Kit is listed under REF VSNUT002 in the LDT-Type PCR Test Kits portfolio. The catalog pack or reaction format is 25/50/100 rxn. Catalog note: Eight-tube expanded UTI 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
Urinary Tract Infections Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Urinary Tract Infections MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation.
Target analyte / scope
Urinary Tract Infections MAXI
Method / technology
Multiplex Real-Time PCR
Pack / reactions
25/50/100 rxn
Internal control present
Yes
Catalog description
Eight-tube expanded UTI panel.
Kit components
Tube 1: E. coli · RNase P · S. agalactiae · K. oxytoca; Tube 2: S. saprophyticus · S. marcescens · P. mirabilis · A. urinae; Tube 3: T. pallidum · E. cloacae · P. aeruginosa · C. freundii; Tube 4: K. aerogenes · K. pneumoniae · M. morganii · C. urealyticum; Tube 5: E. faecium · E. faecalis · A. baumannii · P. vulgaris; Tube 6: S. aureus · U. urealyticum · U. parvum · P. stuartii; Tube 7: C. albicans · C. glabrata · C. parapsilosis · MS2; Tube 8: C. tropicalis · C. krusei · C. auris · 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.
