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 |
