El nuevo Reglamento (UE) 2017/746 del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios para diagnóstico in vitro entró en vigor el 26 de mayo de 2022. Este reglamento deroga la directiva 98/79/CE sobre productos sanitarios para diagnóstico in vitro.

Gracias a un esfuerzo sin precedentes, MDC junto a su partner (Geneproof) ofrecen a sus clientes unos de  los primeros kits en Europa en obtener el Certificado del Sistema de Gestión de Calidad de la UE según el Reglamento Europeo IVDR)

ESTOS SON NUESTROS KITS

Bloodborne Infections

GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/025 HBV/ISEX/100
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/025 HCVD/ISEX/100
GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit HIV1D/GP/025 HIV1D/GP/100

Immunocompromised / Transplanted Panel

GeneProof Cytomegalovirus (CMV) PCR Kit CMV/GP/025 CMV/GP/100
GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/GP/025 EBV/GP/100
GeneProof BK/JC Virus (BK/JC) PCR Kit BKJC/ISEX/025 BKJC/ISEX/100
GeneProof BK Virus (BKV) PCR Kit BKV/GP/025 BKV/GP/100
GeneProof JC Virus (JCV) PCR Kit JCV/GP/025 CV/GP/100
GeneProof Adenovirus PCR Kit ADV/ISEX/025 ADV/ISEX/100
GeneProof Aspergillus PCR Kit ASP/ISEX/025 ASP/ISEX/100
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/GP/025 HSV/GP/100
GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/GP/025 HHV/GP/100
GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit HHV8/GP/025 HHV8/GP/100
GeneProoF Parvovirus B19 PCR Kit B19/ISEX/025 B19/ISEX/100
GeneProof Varicella-Zoster Virus (VZV)PCR Kit VZV/GP/025 VZV/GP/100

Sexually Transmitted Infections Panel

GeneProof Chlamydia trachomatis PCR Kit CHT/GP/025 CHT/GP/100
GeneProof Neisseria gonorrhoeae PCR Kit NG/GP/025 NG/GP/100
GeneProof CT/NG/MG Multiplex PCR Kit CNMX/GP/025 CNMX/GP/100
GeneProof MH/UU/UP Multiplex PCR Kit MUPX/GP/025 MUPX/GP/100
GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/GP/025 MGH/GP/100
GeneProof Ureaplasma PCR Kit UUP/GP/025 UUP/GP/100
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/GP/025 HSV/GP/100
GeneProof Trichomonas vaginalis PCR Kit TV/GP/025 TV/GP/100
GeneProof Treponema pallidum PCR Kit TP/GP/025 TP/GP/100
GeneProof Gardnerella vaginalis PCR Kit GV/GP/025 GV/GP/100

FOR SCREENING PURPOSES

GeneProoF Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/025 HPVS/GP/100

Neuroinfections

GeneProof Borrelia PCR Kit BOR/GP/025 BOR/GP/100
GeneProof Enterovirus PCR Kit EV/ISEX/025 EV/ISEX/100
GeneProof BK/JC Virus (BK/JC) PCR Kit BKJC/ISEX/025 BKJC/ISEX/100
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/GP/025 HSV/GP/100
GeneProof JC Virus (JCV) PCR Kit JCV/GP/025 JCV/GP/100
GeneProof Varicella-Zoster Virus (VZV) PCR Kit VZV/GP/025 VZV/GP/100

Antibiotic Resistance

GeneProof MRSA PCR Kit MRSA/ISEX/025 MRSA/ISEX/100
GeneProof VRE PCR Kit VRE/ISEX/025 VRE/ISEX/100

Respiratory Infections

GeneProof Flu Multiplex PCR Kit FLU/GP/025 FLU/GP/100
GeneProof Enterovirus PCR Kit EV/ISEX/025 EV/ISEX/100
GeneProof Adenovirus PCR Kit ADV/ISEX/025 ADV/ISEX/100
GeneProof Aspergillus PCR Kit ASP/ISEX/025 ASP/ISEX/100
GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/025 BP/ISEX/100
GeneProof Chlaydia pneumoniae PCR Kit CHP/ISEX/025 CHP/ISEX/100
GeneProof Legionella pneumoniae PCR Kit MP/ISEX/025 MP/ISEX/100
GeneProof Mycoplasma pneumoniae PCR Kit MP/ISEX/025 MP/ISEX/100
GeneProof Mycobacterium tuberculosis PCR Kit MT/ISEX/025 MT/ISEX/100

COVID-19 SOLUTION

GeneProof SARS-CoV-2 Advanced PCR Kit COV2A/GP/025 COV2A/GP/100
GeneProof SARS-CoV-2 PCR Kit COV2/GP/025 COV2/GP/100
GeneProoF SARS-CoV-2 Screening PCR Kit COV2S/GP/025 COV2S/GP/100

Thrombotic Mutations

GeneProof Factor II Prothrombin PCR Kit FII/025 FII/100
GeneProof Factor V Leiden PCR Kit FV/025 FV/100
GeneProof Factor XIII V34L PCR Kit FXIII/025 FXIII/100
GeneProof MTHFR C677T PCR Kit M677/025 M677/GP/100
GeneProof MTHFR A1298C PCR Kit M1298/025 M1298/100
GeneProof PAI-1 Genotyping PCR Kit PAI1/025 PAI1/100

Extraction Kits and Accessories

GeneProof Universal Internal Control UNIC/GP/050
GeneProof PathogenFree DNA Isolation Kit IDNA050
GeneProof PathogenFree RNA Isolation Kit IRNA050
croBEE 201A Nucleic Acid Extraction Kit CBNA201A/096
croBEEªmax Nucleic Acid Extraction Kit CBMAX200/192
myCROBE/croBEE 2.0 Universal Extraction Kit MC200/036