Infectious diseasesBacteriology (infect. immunology/NAT)Lyme borreliosis

Lyme antibody igm

EMDN code W0105010604

17 manufacturers, 59 models including 59 on the market, 7 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 17

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 Borrelia afzelii IgM98/79 BLOT-LINE Borrelia b. sensu stricto IgM98/79 BLOT-LINE Borrelia garinii IgM98/79 BLOT-LINE Borrelia/HGA IgM98/79 BlueBLOT-LINE Borrelia IgM98/79 12 others CLIA Borrelia CSF IgM CLIA Borrelia recombinant IgM98/79 EIA Borrelia afzelii IgM (192)98/79 EIA Borrelia garinii IgM (192)98/79 EIA Borrelia IgM98/79 EIA Borrelia recombinant IgM (192)98/79 Microblot-Array Borrelia IgM98/79 SmartEIA Borrelia afzelii IgM98/79 SmartEIA Borrelia b. sensu stricto IgM98/79 SmartEIA Borrelia garinii IgM98/79 SmartEIA Borrelia IgM98/79 SmartEIA Borrelia recombinant IgM98/79	B IVDR, 98/79	Website info@testlinecd.com EUDAMED record Report an error
Euroimmun FDA	Germany	Anti-Borrelia afzelii-WESTERNBLOT (IgM) DY 2131 M2 refs98/79 Anti-Borrelia burgdorferi-WESTERNBLOT (IgM) DY 2132 M2 refs98/79 Anti-Borrelia ChLIA (IgM) LI 2132 M98/79 Anti-Borrelia CSF ELISA 2.0 (IgM) EI 2132-2L M Anti-Borrelia ELISA (IgM) EI 2132 M98/79 8 others Anti-Borrelia EUROLINE-RN-AT (IgM) DN 2131 M3 refs98/79 Anti-Borrelia EUROLINE-RN-AT-11 (IgM) DN 2131-11 M2 refs98/79 Anti-Borrelia EUROLINE-RN-AT-adv (IgM) DN 2131-2 M3 refs98/79 Anti-Borrelia EUROLINE-WB (IgM) DY 2131-1 M4 refs98/79 Anti-Borrelia garinii-WESTERNBLOT (IgM) DY 2134 M2 refs98/79 Anti-Borrelia Select ELISA (IgM) EI 2132-5 M98/79 EUROMicroblot Anti-Borrelia (IgM) KN 2131 M98/79 IIFT: Borrelia afzelii / VlsE / Borrelia burgdorferi / OspC (IgM) FI 2136-1 M2 refs98/79	B IVDR, 98/79	Website info@euroimmun.de EUDAMED record Report an error
Mikrogen	Germany	recomBead Borrelia IgM 2.098/79 recomCLIA Borrelia IgM recomLine Borrelia IgM2 refs98/79 recomWell Borrelia IgM98/79	B IVDR, 98/79	EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Borrelia afzelii IgM98/79 Borrelia garinii IgM98/79 Borrelia recombinant IgM98/79	– 98/79	Website EUDAMED record Report an error
Seramun	Germany	Seraline® Anti-Borrelia-8 IgM2 refs98/79 SeraSpot® Anti-Borrelia IgM3 refs SeraSpot® Anti-Borrelia-10 IgM3 refs98/79	B IVDR, 98/79	info@seramun.com EUDAMED record Report an error
Viramed FDA	Germany	Borrelia ViraChip IgM Antigen Coated Wells Lyme IgM Antibodies Borrelia ViraChip IgM Deca Kit2 refs Borrelia ViraChip IgM Positive Control	B IVDR	Website EUDAMED record Report an error
Aesku FDA	Germany	AESKUBLOTS® Borrelia-M98/79 AESKULISA® Borrelia-M98/79	– 98/79	Website EUDAMED record Report an error
DiaSorin FDA	Italy	LIAISON® Borrelia IgM II LIAISON® Borrelia IgM Quant	B IVDR	Website EUDAMED record Report an error
Gold Standard Diagnostics FDA	Germany	Borrelia burgdorferi IgM98/79 NovaLisa® Borrelia burgdorferi IgM98/79	– 98/79	info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Orgentec	Germany	Anti-Borrelia IgM Abs.98/79 Anti-Borrelia IgM Liquor98/79	– 98/79	Website EUDAMED record Report an error
Vidia	Czechia	ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)4 refs98/79 MONO-VIDITEST anti-Borrelia sp. IgM2 refs98/79	– 98/79	Website EUDAMED record Report an error
AIDA	Germany	Borrelia IgM98/79	– 98/79	EUDAMED record Report an error
bioMérieux FDA	France	VIDAS® Lyme IgM	B IVDR	EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Lyme Borrelia IgG/IgM Rapid Test98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
IBL International	Germany	Borrelia 14kDa + OspC IgM ELISA98/79	– 98/79	Website EUDAMED record Report an error
Technogenetics FDA	Italy	IDS Borrelia IgM	B IVDR	Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Vircell	Spain	BORRELIA VIRCLIA® IgM MONOTEST VCM010	B IVDR	EUDAMED record Report an error

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