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GeneProof a.s.

Czechia·CZ-MF-000002370

Last updated September 17, 2026

About

GeneProof is the biotechnological company providing customers with technologically advanced solutions in the field of molecular in vitro diagnostics of serious infections and genetic diseases. We are engaged in the development, manufacturing and distribut

From the manufacturer's own website. Source

What GeneProof a.s. makes

The company produces in vitro diagnostic (IVD) PCR kits for detecting specific pathogens and genetic markers, including Bordetella pertussis/parapertussis, adenovirus, Chlamydia pneumoniae, Mycobacterium tuberculosis, human papillomavirus (HPV), and Trichomonas vaginalis. It also offers genotyping and multiplex PCR kits for conditions like MTHFR C677T, PAI1, and flu infections, alongside a stool extraction device for sample preparation.

These devices fall under EU IVD classifications, including Class A, Class B, Class C, and Annex II List A, with some classified under the broader IVD General category. The products are registered in the EU’s eudamed database, and the manufacturer is based in the Czech Republic.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Czechia
Address: 101/119, Vídeňská, Brno, Czechia
Website: www.geneproof.com
LinkedIn: cz.linkedin.com/company/geneproof-a-s-
Facebook: facebook.com/GeneProof-as-380982398933950
Email: [email protected]
Phone: +420 543 211 679
PRRC Contact: Eva Horňáková
EUDAMED SRN: CZ-MF-000002370
FDA FEI Number: —
DUNS Number: —

Catalogue (109)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
TaqPath™ Menu \| GeneProof™ Mycoplasma pneumoniae PCR Kit	A58210	EUDAMED	IVD General	Active
GeneProof Factor XIII V34L PCR Kit	FXIII/025	EUDAMED	IVD General	Active
GeneProof Chlamydia trachomatis PCR Kit	CT/GP/025	EUDAMED	Class C	Active
GeneProof MTHFR A1298C PCR Kit	M1298/025	EUDAMED	IVD General	Active
GeneProof Mycoplasma pneumoniae PCR Kit	MP/ISEX/025	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Adenovirus PCR Kit	A58213	EUDAMED	IVD General	Active
GeneProof Human Papillomavirus (HPV) Screening PCR Kit	HPVS/GP/100	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Treponema pallidum PCR Kit	A58125	EUDAMED	IVD General	Active
GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit	HHV8/GP/100	EUDAMED	Class C	Active
GeneProof MH/UU/UP Multiplex PCR Kit	MUPX/GP/100	EUDAMED	Class C	Active
GeneProof Chlamydia trachomatis PCR Kit	CT/GP/100	EUDAMED	Class C	Active
GeneProof Aspergillus PCR Kit	ASP/ISEX/100	EUDAMED	IVD General	Active
GeneProof Gardnerella vaginalis PCR Kit	GV/GP/100	EUDAMED	IVD General	Active
GeneProof Mycoplasma genitalium/hominis PCR Kit	MGH/GP/100	EUDAMED	Class C	Active
GeneProof Mycoplasma pneumoniae PCR Kit	MP/ISEX/100	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Factor V Leiden PCR Kit	A58421	EUDAMED	IVD General	Active
GeneProof Urine Pretreatment Sample Tube	MC206/540	EUDAMED	Class A	Active
GeneProof Blood Pretreatment Sample Tube	MC203/540	EUDAMED	Class A	Active
GeneProof SARS-CoV-2 Advanced PCR Kit	COV2A/GP/100	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Trichomonas vaginalis PCR Kit	A58126	EUDAMED	IVD General	Active
GeneProof Enterovirus PCR Kit	EV/ISEX/025	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Human Herpesvirus 8 (HHV-8) PCR Kit	A58434	EUDAMED	Class C	Active
GeneProof SARS-CoV-2 Advanced PCR Kit	COV2A/GP/025	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ CT/NG/MG Multiplex PCR Kit	A58117	EUDAMED	Class C	Active
GeneProof CT/NG/MG Multiplex PCR Kit	CNMX/GP/025	EUDAMED	Class C	Active
GeneProof Human Papillomavirus (HPV) Screening PCR Kit	HPVS/GP/025	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Chlamydia trachomatis PCR Kit	A58121	EUDAMED	Class C	Active
GeneProof Adenovirus PCR Kit	ADV/ISEX/025	EUDAMED	IVD General	Active
GeneProof Mycobacterium tuberculosis PCR Kit	MT/ISEX/100	EUDAMED	IVD General	Active
GeneProof Varicella-Zoster Virus (VZV) PCR Kit	VZV/GP/025	EUDAMED	Class C	Active
TaqPath™ Menu \| GeneProof™ HIV type 1 (HIV-1) Diagnostic PCR Kit	A58119	EUDAMED	IVD Annex II List A	Active
GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit	HIV1D/GP/100	EUDAMED	IVD Annex II List A	Active
TaqPath™ Menu \| GeneProof™ Universal Internal Control	A58250	EUDAMED	Class B	Active
GeneProof Epstein-Barr Virus (EBV) PCR Kit	EBV/GP/025	EUDAMED	Class C	Active
GeneProof PathogenFree DNA Isolation Kit	IDNA050	EUDAMED	Class A	Active
GeneProof Universal Internal Control	UNIC/GP/010	EUDAMED	Class B	Active
TaqPath™ Menu \| GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit	A58427	EUDAMED	IVD Annex II List A	Active
TaqPath™ Menu \| GeneProof™ Epstein-Barr Virus (EBV) PCR Kit	A58429	EUDAMED	IVD General	Active
GeneProof Varicella-Zoster Virus (VZV) PCR Kit	VZV/GP/100	EUDAMED	Class C	Active
TaqPath™ Menu \| GeneProof™ Cytomegalovirus (CMV) PCR Kit	A58428	EUDAMED	Class C	Active
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit	HCVD/ISEX/025	EUDAMED	IVD Annex II List A	Active
GeneProof JC Virus (JCV) PCR Kit	JCV/GP/100	EUDAMED	Class C	Active
croGENE Real-Time PCR System	CGRT6/96	EUDAMED	Class A	Active
GeneProof Cytomegalovirus (CMV) PCR Kit	CMV/GP/100	EUDAMED	Class C	Active
GeneProof Hepatitis B Virus (HBV) PCR Kit	HBV/ISEX/025	EUDAMED	IVD Annex II List A	Active
TaqPath™ Menu \| GeneProof™ JC Virus (JCV) PCR Kit	A58436	EUDAMED	IVD General	Active
TaqPath™ Menu \| GeneProof™ Herpes Simplex Virus (HSV-1/2) PCR Kit	A58128	EUDAMED	IVD General	Active
GeneProof BK Virus (BKV) PCR Kit	BKV/GP/100	EUDAMED	Class C	Active
GeneProof Epstein-Barr Virus (EBV) PCR Kit	EBV/GP/100	EUDAMED	Class C	Active
GeneProof Universal Internal Control	UNIC/GP/050	EUDAMED	Class B	Active

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