Infectious diseasesBacteriology (infect. immunology/NAT)Syphilis (treponema pallidum)

Syphilis antibody assays total

EMDN code W0105010302

67 manufacturers, 114 models including 111 on the market, 14 countries

On the market in Models on the market only Manufacturer country

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
Dialab	Austria	Anti-Syphilis Ab Z0436698/79 Anti-Syphilis Ab Z0936898/79 Syphilis RPR2 refs98/79 Syphilis RPR Carbon Reagent98/79 Syphilis TPHA3 refs98/79 1 other Syphilis VDRL2 refs98/79	– 98/79	Website office@dialab.at EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain)	China	100T/kit98/79 15T/kit98/79 1T/kit98/79 40T/kit98/79 5T/kit98/79	– 98/79	EUDAMED record Report an error
Bio-Rad	France	RPR2 refs Syphilis Total Ab 7253098/79 Syphilis Total Ab 7253198/79 TPHA 7250398/79 TPHA 7250498/79	C IVDR, 98/79	Website contact@bio-rad.com EUDAMED record Report an error
Lifotronic EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Syphilis (eCLIA) 100T98/79 Syphilis (eCLIA) 2×100T98/79 Syphilis (eCLIA) 2×50T98/79 Syphilis (eCLIA) 50T98/79	– 98/79	Website EUDAMED record Report an error
Newmarket Biomedical EU representative : MDSS GmbH (Germany)	United Kingdom (ex Northern Ireland)	NewBio Syphilis EIA TA - 96 Test Kit98/79 Newbio TPHA 1003 refs NewBio TPHA plus 100 test kit3 refs PK7400 TP HA Reagent98/79	C IVDR, 98/79	Website regulatory@new-bio.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 Syphilis Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 100 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 200 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Dirui EU representative : Emergo Europe B.V. (Netherlands)	China	Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×100 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×50 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 2×50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	RPR Syphilis Test 725 00098/79 RPR Syphilis Test 725 00198/79 RPR Syphilis Test 725 00298/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Syphilis Rapid Test Cassette ISY-402H98/79 Syphilis Rapid Test Cassette ISY-R40298/79 Syphilis Test Cassette FI-SYP-40298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Trinitybiotech EU representative : TrinityBiotech (Ireland)	United States	Bio-Stat Syphilis EIA Test Kit YY6012698/79 Captia Syphilis TA EIA Test Kit 232217098/79 Captia Syphilis TA EIA Test Kit 232217198/79	– 98/79	Website EUDAMED record Report an error
Wondfo EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	One Step Syphilis Serum/Plasma Test2 refs98/79 One Step Syphilis Whole Blood/Serum/Plasma Test4 refs98/79 SmarLumi4 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands)	China	Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 100 Tests/Kit98/79 Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 25 Tests/Kit98/79 Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay) 50 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Atlas Medical	Germany	Atlas Syphilis Antibody Test Device, Whole Blood /Serum /Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas Syphilis Antibody Test Strip, Serum/Plasma, Individually Pouched, 50 Tests/Box 8.04.43.0.005098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium)	China	Rapid Test for Antibody to Syphilis (Colloidal Gold Device)2 refs98/79 WANTAI anti-TP ELISA98/79	– 98/79	EUDAMED record Report an error
Diesse	Italy	CHORUS SYPHILIS SCREEN RECOMBINANT CHORUSTPN TPHA-DAT ADVANCED TPHAD	C IVDR	Website EUDAMED record Report an error
Euroimmun	Germany	Anti-Treponema pallidum ELISA 2.0 (IgGM) EI 2111-2 O Anti-Treponema pallidum Screen ELISA (IgGM) EI 2111 O98/79	C IVDR, 98/79	Website info@euroimmun.de EUDAMED record Report an error
Genesignbio EU representative : SUNGO Europe B.V. (Netherlands)	China	1 test/kit98/79 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Getein EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Anti-TP Fast Test Kit (Immunofluorescence Assay)8 refs98/79 MAGICL Syphilis (CLIA)	C IVDR, 98/79	EUDAMED record Report an error
Hightopbio EU representative : MedNet EC-REP GmbH (Germany)	China	Antibodies to Treponema Pallidum (TP) ELISA Test Kit (Serum/Plasma)98/79 Syphilis TP Reagent Kit（Microparticles Chemiluminescent Immunoassay）98/79	– 98/79	Website EUDAMED record Report an error
LTA	Italy	Syphilis TPHA 100 Tests98/79 Syphilis TPHA 200 Tests98/79	– 98/79	Website office@ltaonline.it EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o	Czechia	EIA Treponema pallidum TOTAL98/79 SmartEIA Treponema pallidum TOTAL98/79	– 98/79	Website info@testlinecd.com EUDAMED record Report an error
Tianjin Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	100 TEST/KIT98/79 500 TEST/KIT98/79	– 98/79	EUDAMED record Report an error
Vircell	Spain	SYPHILIS ELISA IgG+IgM T106098/79 SYPHILIS VIRCLIA® IgG+IgM MONOTEST VCM08698/79	– 98/79	EUDAMED record Report an error
ZEUS Scientific EU representative : Emergo Europe B.V. (Netherlands)	United States	FTA-ABS DS Test System FA7001DS98/79 FTA-ABS Test System FA700198/79	– 98/79	Website regulatory@zeusscientific.com EUDAMED record Report an error
Acro Biotech EU representative : MedNet EC-REP GmbH (Germany)	United States	Syphilis Test Cassette (Whole Blood/ Serum/ Plasma) ACO-SYP-40298/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Adaltis	Italy	EIAgen Syphilis Ab Kit98/79	– 98/79	Website info@adaltis.net EUDAMED record Report an error
Aichek EU representative : Medunion S.L. (Spain)	China	Anti-TP Treponema Pallidum Antibody (CLIA)98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Anhui Deepblue Medical Technology EU representative : Luxus Lebenswelt GmbH (Germany)	China	TP Syphilis Antibody Test Kit Cassette Strip7 refs98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Treponema pallidum antibodyTest Kit98/79	– 98/79	EUDAMED record Report an error
Bio-Novum	Poland	BN Syphilis Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Bosonbio EU representative : MedPath GmbH (Germany)	China	Treponema Pallidum Antibody assay (CLIA)98/79	– 98/79	Website EUDAMED record Report an error
Chronolab	Spain	TPHA, 200 tests98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
CTK Biotech EU representative : MDSS GmbH (Germany)	United States	Aria® Syphilis Ab Combo Rapid Test R0031C3 refs	C IVDR	Website info@ctkbiotech.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	The Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA) C2KC00998/79	– 98/79	info@cybereagen.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	96 tests/kit98/79	– 98/79	EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
Diagnostics	Belgium	Syphilis Ab Rapid C 35398/79	– 98/79	Website EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain)	China	Syphilis Antibody Rapid Test Kit 25 tests/box	C IVDR	Website info@diagreat.com EUDAMED record Report an error
Diapro	Italy	Syphilis Screen ELISA 5100498/79	– 98/79	Website info@diapro.it EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	RapiSyph Rapid Antibody Test kit for Syphilis G2MR17251598/79	– 98/79	Website EUDAMED record Report an error
Giesse Diagnostics	Italy	TPHA 202998/79	– 98/79	Website info@giessediagnostics.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Treponema Pallidum Antibody Rapid Test P23111198/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Syphilis Antibody Rapid Test HTP063T98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Hotgen EU representative : MedNet EC-REP GmbH (Germany)	China	One Step Syphilis Anti-TP Test (Colloidal Gold) Please see the IFU2 refs	C IVDR	service@hotgen.com.cn EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Treponema Pallidum Antibody Kit (Microfluidic Fluorescent Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Syphilis Antibody Test (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium)	China	TP Ab CLIA2 refs98/79	– 98/79	Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	RPR Syphilis Test98/79	– 98/79	EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Treponema Pallidum Antibody（Anti-TP）Assay Kit 100 Tests98/79	– 98/79	EUDAMED record Report an error
Linear	Spain	Cromatest2 refs98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Livzondiagnostics EU representative : QbD RepS BV (Belgium)	China	100 tests/kit (20×5)；220 tests/kit (55 × 4)2 refs	C IVDR	Website ra@livzondiagnostics.com EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)3 refs98/79	– 98/79	Website EUDAMED record Report an error
MedicalSystem Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Treponema Pallidum Antibodies Kit(CLIA) 100T98/79	– 98/79	EUDAMED record Report an error
Mindray EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Anti-Thyrotropin Receptor Antibody (CLIA) 105-010975-00/105-010976-00/105-010214-00/105-020852-00	B IVDR	Website EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA) C2KJ00198/79	– 98/79	Website info@realytech.com EUDAMED record Report an error
Shenzhen Yhlo Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iFlash-Anti-TP3 refs	C IVDR	Website info@szyhlo.com EUDAMED record Report an error
Siemens Healthcare Diagnostics EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	Atellica IM Syphilis (Syph) DX LS_LEGACY_0063041459988598/79	– 98/79	Website contact@siemens-healthineers.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	RPR Syphilis Test4 refs98/79	– 98/79	Website EUDAMED record Report an error
Spinreact	Spain	TPHA No98/79	– 98/79	Website EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	Syphilis (TP) Antibody Rapid Test Kit98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™3 refs	C IVDR	Website info@vitrosens.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	TPHA HIZLI TEST KİTİ	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands)	China	96 tests/kit98/79	– 98/79	EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) No model still on the market	China	Treponema pallidum Antibody Rapid Qualitative Test BT010270198/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Deben Diagnostics EU representative : EU-UK Authorised Representative Ltd (Northern Ireland) No model still on the market	United Kingdom (ex Northern Ireland)	Haemagglutination Assay (TPHA) Kit3 refs98/79 (no longer marketed)	– 98/79	Website info@debendiagnostics.co.uk EUDAMED record Report an error
Nantong EgensBiotechnology EU representative : SUNGO Europe B.V. (Netherlands) No model still on the market	China	Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold) TP strip cassette98/79 (no longer marketed)	– 98/79	qa@egens-bio.cn EUDAMED record Report an error

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