ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Cytomegalovirus

EMDN code W01050402

46 manufacturers, 125 models including 120 on the market, 12 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 46

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

Manufacturer	Country	Registered models	Class	Contact
TestLine Clinical Diagnostics s.r.o	Czechia	BLOT-LINE CMV IgG98/79 BLOT-LINE CMV IgM98/79 CLIA CMV IgG98/79 CLIA CMV IgM98/79 EIA CMV IgG98/79 5 others EIA CMV IgM98/79 Microblot-Array CMV IgG Microblot-Array CMV IgM SmartEIA CMV IgG98/79 SmartEIA CMV IgM98/79	C IVDR, 98/79	Website info@testlinecd.com EUDAMED record Report an error
Vidia	Czechia	ELISA-VIDITEST anti-CMV IgG2 refs98/79 ELISA-VIDITEST anti-CMV IgG (CSF)5 refs98/79 ELISA-VIDITEST anti-CMV IgG a avidita IgG2 refs98/79 ELISA-VIDITEST anti-CMV IgG and IgG avidity98/79 ELISA-VIDITEST anti-CMV IgM2 refs98/79 4 others MONO-VIDITEST anti-CMV IgG2 refs98/79 MONO-VIDITEST anti-CMV IgG avidita98/79 MONO-VIDITEST anti-CMV IgG avidity98/79 MONO-VIDITEST anti-CMV IgM2 refs98/79	– 98/79	Website EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-CMV ELISA (IgG) EI 2570 G98/79 Anti-CMV ELISA (IgM) EI 2570 M98/79 Anti-CMV gB ELISA (IgG) EI 2570-3 G98/79 Anti-CMV p52 ELISA (IgM) EI 2570-2 M98/79 Avidity: Anti-CMV ELISA (IgG) EI 2570-1 G98/79 3 others CSF: Anti-CMV ELISA (IgG) EI 2570-L G98/79 EUROLINE Anti-CMV (IgG) DN 2570-2 G3 refs EUROLINE Anti-CMV (IgM) DN 2570-2 M3 refs	C IVDR, 98/79	Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Avidity Cytomegalovirus (CMV) IgG ELISA98/79 Cytomegalovirus (CMV) IgG ELISA98/79 Cytomegalovirus (CMV) IgG RE5706198/79 Cytomegalovirus (CMV) IgM ELISA98/79 Cytomegalovirus (CMV) IgM RE5707198/79 3 others NovaLisa® Avidity Cytomegalovirus (CMV) IgG98/79 NovaLisa® Cytomegalovirus (CMV) IgG2 refs98/79 NovaLisa® Cytomegalovirus (CMV) IgM2 refs98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Viramed FDA	Germany	CMV ViraChip IgG Antigen Coated Wells CMV IgG Antibodies2 refs CMV ViraChip IgG Deca Kit2 refs CMV ViraChip IgG Positive Control3 refs CMV ViraChip IgM Antigen Coated Wells CMV IgM Antibodies2 refs CMV ViraChip IgM Deca Kit2 refs 1 other CMV ViraChip IgM Positive Control2 refs	C IVDR	Website EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™3 refs ChainFor™ CFP109P2598/79 ChainFor™ CFP109P5098/79 LyoSens CMV Detection qPCR Kit LYO4298/79 LyoSens™ LYO109WS4898/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	Ireland, United States	Alinity9 refs Alinity m6 refs ARCHITECT10 refs RealTime3 refs	C IVDR, 98/79	Website EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark)	Singapore	FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use (Dako Omnis) GA75298/79 FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clone CCH2 + DDG9, Ready-to-Use (Dako Omnis) GA752/IR752 FLEX Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9, Ready-to-Use (Link) IR75298/79 Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9 M085498/79	C IVDR, 98/79	Website info.dk@agilent.com EUDAMED record Report an error
bioMérieux FDA	France	CMV R-GENE® 69-003B VIDAS® CMV IgG VIDAS® CMV IgG Avidity II VIDAS® CMV IgM	C IVDR	EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	Italy, United States	LIAISON® CMV IgG Avidity II LIAISON® CMV IgG II98/79 Simplexa™ Congenital CMV Direct Simplexa™ Congenital CMV Positive Control Pack	C IVDR, 98/79	Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Diesse FDA	Italy	CHORUS CYTOMEGALOVIRUS IgG CHORUSCMVIGG CHORUS CYTOMEGALOVIRUS IgM CAPTURE CHORUSCMVIGMCA CHORUS CYTOMEGALOVIRUS IgM CHORUSCMVIGM	C IVDR	Website EUDAMED record Report an error
Technogenetics FDA	Italy	IDS CMV IgG IDS CMV IgG Avidity IDS CMV IgM	C IVDR	Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Japan	CL AIA-PACK CMV IgG ADJUSTER SET98/79 CL AIA-PACK CMV IgG TEST CUP98/79 CL AIA-PACK CMV IgM ADJUSTER SET2 refs	C IVDR, 98/79	csc@tosoh.co.jp EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SA CMV Controls Set (8x3) 30062498/79 Sentosa SA CMV Quantitation Controls (4x2) 30005998/79 Sentosa SA CMV Quantitative PCR Test (4x24) 30011498/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Aesku FDA	Germany	AESKULISA® Cytomegalovirus IgG98/79 AESKULISA® Cytomegalovirus IgM98/79	– 98/79	Website EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® CMV PCR Kit 1.5 RealStar® CMV PCR Kit 1.098/79	C IVDR, 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium)	China	CMV IgG CLIA Microparticles Autolumo analyzer3 refs CMV IgM CLIA Microparticles Autolumo analyzer3 refs	C IVDR	info@autobio-diagnostics.com EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland)	United States	Access CMV IgG A4070298/79 Access CMV IgM A4070598/79	– 98/79	Website EUDAMED record Report an error
Clonit	Italy	quanty CMV RT-1298/79 quanty CMVqs QS-1298/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
ElitechGroup FDA	Italy	CMV - ELITe Positive Control3 refs CMV RNA - ELITe Positive Control3 refs	C IVDR	Website EUDAMED record Report an error
Geneproof	Czechia	GeneProof Cytomegalovirus (CMV) MC PCR Kit2 refs GeneProof Cytomegalovirus (CMV) PCR Kit3 refs	C IVDR	Website support@geneproof.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	CMV IgM Rapid Test Cassette (Serum/Plasma) ICM-30298/79 CMV IgM Rapid Test Cassette ICM-30298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Mikrogen	Germany	recomLine CMV IgG [Avidität]98/79 recomLine CMV IgM	C IVDR, 98/79	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Cytomegalovirus IgG (CLIA) 105-012536-00, 105-012537-00, 105-012539-00, 105-012540-003 refs Cytomegalovirus IgM (CLIA) 105-012542-00, 105-012543-00, 105-012545-00, 105-012546-003 refs	C IVDR	Website EUDAMED record Report an error
Qiagen FDA	Germany	artus CMV QS-RGQ Kit98/79 artus CMV RG PCR Kit2 refs98/79	– 98/79	Website info@qiagen.com EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi	Türkiye	RTA CMV Real Time PCR Kit2 refs98/79 RTA CMV Real Time PCR Kit, v2.03 refs98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iFlash-CMV IgG3 refs iFlash-CMV IgM3 refs	C IVDR	Website info@szyhlo.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur CMV IgM (CMV IgM) IVDR_67_TTN_DUB-C_C_REAG_KIT_CMV IgM2 refs ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) IVDR_67_TTN_DUB-C_C_REAG_CMV IgM QC2 refs	C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United Kingdom (ex Northern Ireland)	IMMULITE 2000 CMV IgG IVDR_67_LLB_DUB-C_C_REAG_KIT_CMV IgG IMMULITE 2000 CMV IgM IVDR_67_LLB_DUB-C_C_KIT_CMV IgM	C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland)	United States	Captia™ Cytomegalovirus IgM kit 232526098/79 Captia™ Cytomegalovirus IgM kit 232526198/79	– 98/79	Website EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® CMV QT Kit3 refs	C IVDR	Website info@3bblackbio.com EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-CMV4 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks3 refs	C IVDR	Website info@anatoliagenetik.com EUDAMED record Report an error
Anchor Diagnostics	Germany	ANCHOR CMV PCR Kit2 refs	C IVDR, 98/79	info@anchor-diagnostics.com EUDAMED record Report an error
Bioperfectus FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Human Cytomegalovirus Real Time PCR Kit2 refs	C IVDR	EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima CMV Quant Assay3 refs	C IVDR	EUDAMED record Report an error
Human	Germany	CMV IgG98/79	– 98/79	Website EUDAMED record Report an error
Iontek	Türkiye	Fluorion CMV QNP 3.0 Real-Time PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy)	United States	Alethia CMV	C IVDR	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	D3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Sentinel FDA	Italy	STAT-NAT® SN200 CMV CMV 1	C IVDR	Website EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Human Cytomegalovirus (HCMV) Quantitative Real Time PCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	CMV MİKTAR TEST KİTİ	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) No model still on the market	China	100 Tests/Kit2 refs98/79 (no longer marketed) 200 Tests/Kit2 refs98/79 (no longer marketed) 30 Tests/Kit4 refs98/79 (no longer marketed) 50 Tests/Kit4 refs98/79 (no longer marketed)	– 98/79	Website support@rayto.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	CMV(Cytomegalovirus) IGG IGM Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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