— LDT-Type PCR Test Kits

Antibiotic Resistance Gene Panel MAXI Kit

REF VSNAR00225/50/100 rxnIVDR Application Active

Antibiotic Resistance Gene Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Antibiotic Resistance Gene MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation. Antibiotic Resistance Gene Panel MAXI Kit is listed under REF VSNAR002 in the LDT-Type PCR Test Kits portfolio. The catalog pack or reaction format is 25/50/100 rxn. Catalog note: Eight-tube expanded resistance gene 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
Antibiotic Resistance Gene Panel MAXI Kit is listed for laboratory-developed testing workflows using Multiplex Real-Time PCR, with the catalog name identifying Antibiotic Resistance Gene MAXI as its target scope. Laboratory validation, configuration and local-use requirements must be checked against controlled documentation.
Target analyte / scope
Antibiotic Resistance Gene MAXI
Method / technology
Multiplex Real-Time PCR
Pack / reactions
25/50/100 rxn
Internal control present
Yes
Catalog description
Eight-tube expanded resistance gene panel.
Kit components
Tube 1: RNase P · VIM · NDM; Tube 2: IMP · OXA · qnrB; Tube 3: mecA/mecC · vanA · vanB; Tube 4: SUL · CTX · dfrA; Tube 5: ermB · tetM · AmpC; Tube 6: SHV · qnrA · C6-1b/aacA4; Tube 7: aac(6′)-Ib-cr · qnrS · vanC1; Tube 8: KPC · ermA · ermC
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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