Manufacturer

altona Diagnostics

GermanyLegal entities : altona Diagnostics GmbH

Markets : Austria · Belgium · France · Germany · Ireland · Italy · Spain · United States

Approvals : EU – class A, B, C · United States (FDA) – · class I

Public contracts won : Italy 2 · Belgium 1 · France 1 · Germany 1

info@altona-diagnostics.com

41 categories, 71 models including 71 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Coronavirus - NA reagents	W0105041106	AltoStar® MERS-CoV RT-PCR Kit 1.598/79 AltoStar® SARS-CoV-2 RT-PCR Kit 1.598/79 RealStar® MERS-CoV RT-PCR Kit 1.098/79 RealStar® SARS-CoV-2 RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	AltoStar® alpha Herpesvirus PCR Kit 1.5 FlexStar® Norovirus Type & Rotavirus RT-PCR Detection Mix 1.598/79 FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.598/79 RealStar® alpha Herpesvirus PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	AltoStar® EBV PCR Kit 1.5 RealStar® EBV PCR Kit 1.098/79 RealStar® EBV PCR Kit 2.098/79	C IVDR, 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	AltoStar® Influenza Screen & Type RT-PCR Kit 1.598/79 RealStar® Influenza Screen & Type RT-PCR Kit 4.098/79 RealStar® PIV RT-PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Parasitology - other	W0105050299	RealStar® Chagas PCR Kit 1.098/79 RealStar® Malaria PCR Kit 1.098/79 RealStar® Malaria Screen & Type PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	FlexStar® CT & NG PCR Detection Mix 1.5 FlexStar® MG & UU & TV PCR Detection Mix 1.5 FlexStar® UP & MH PCR Detection Mix 1.5	C IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	RealStar® Lassa Virus RT-PCR Kit 2.098/79 RealStar® Rift Valley Fever Virus RT-PCR Kit 1.098/79 RealStar® Yellow Fever Virus RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	AltoStar® Adenovirus PCR Kit 1.5 RealStar® Adenovirus PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	AltoStar® BKV PCR Kit 1.5 RealStar® BKV PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	FlexStar® Bordetella PCR Detection Mix 1.5 RealStar® Bordetella PCR Kit 1.098/79	B IVDR, 98/79	EUDAMED record Report an error
Cmv - NA reagents	W0105040205	AltoStar® CMV PCR Kit 1.5 RealStar® CMV PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	RealStar® Dengue RT-PCR Kit 2.098/79 RealStar® Dengue RT-PCR Kit 3.098/79	– 98/79	EUDAMED record Report an error
Hepatitis e virus - NA reagents	W0105020507	AltoStar® HEV RT-PCR Kit 1.5 RealStar® HEV RT-PCR Kit 2.098/79	C IVDR, 98/79	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	AltoStar® HHV-6 PCR Kit 1.5 RealStar® HHV-6 PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	AltoStar® HSV PCR Kit 1.5 RealStar® HSV PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Jc virus - NA reagents	W0105040523	AltoStar® JCV PCR Kit 1.5 RealStar® JCV PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	AltoStar® Norovirus RT-PCR Kit 1.5 RealStar® Norovirus RT-PCR Kit 3.098/79	B IVDR, 98/79	EUDAMED record Report an error
Parvovirus b 19 - NA reagents	W0105040509	AltoStar® Parvovirus B19 PCR Kit 1.5 RealStar® Parvovirus B19 PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	AltoStar® Purification Kit 1.5 ExtraStar® Purification Kit 2.0	A IVDR	EUDAMED record Report an error
Supplemental NA reagents	W0105900103	AltoStar® Respiratory Sample Pretreatment Buffer 1.5 AltoStar® Whole Blood Pretreatment Buffer 1.5	A IVDR	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	AltoStar® VZV PCR Kit 1.5 RealStar® VZV PCR Kit 1.098/79	C IVDR, 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	RealStar® Clostridium difficile PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	RealStar® Chikungunya RT-PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	AltoStar® Internal Control 1.5	B IVDR	EUDAMED record Report an error
Crimean-congo hemorrhagic fever (cchf) - NA reagents	W0105040529	RealStar® CCHFV RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
E. coli detection by NA reagents	W0105011503	RealStar® EHEC PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Ebola (filovirus) - NA reagents	W0105040528	RealStar® Filovirus Screen RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	RealStar® Enterovirus RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
Hepatitis a virus - NA reagents	W0105020105	AltoStar® HAV RT-PCR Kit 1.5	C IVDR	EUDAMED record Report an error
Hepatitis c virus - NA reagents	W0105020307	AltoStar® HCV RT-PCR Kit 1.598/79	– 98/79	EUDAMED record Report an error
HIV 1 - NA reagents	W0105030107	AltoStar® HIV RT-PCR Kit 1.598/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus - NA reagents	W0105040517	RealStar® hMPV RT-PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	RealStar® Pneumocystis jirovecii PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - NA reagents	W0105050309	AltoStar® Malaria PCR Kit 1.5	C IVDR	EUDAMED record Report an error
Pneumocystis - NA reagents	W0105060405	AltoStar® Pneumocystis jirovecii PCR Kit 1.5	C IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	FlexStar® (RT-)PCR Amplification Mix 1.52 refs	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	RealStar® RSV RT-PCR Kit 3.098/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	FlexStar® FLU Type & RSV RT-PCR Detection Mix 1.5	B IVDR	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	RealStar® Rotavirus RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error
West nile virus - NA reagent	W0105040526	RealStar® WNV RT-PCR Kit 2.098/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	RealStar® Zika Virus RT-PCR Kit 1.098/79	– 98/79	EUDAMED record Report an error

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