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

Syphilis reagents other

EMDN code W0105010399

14 manufacturers, 36 models including 33 on the market, 9 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 14

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
Atlas Medical FDA	Germany	Atlas RPR Carbon Antigen Kit, 100 Tests 8.00.18.0.010098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls) 8.00.18.3.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks). 8.00.18.2.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks, White Glass Slide). 8.00.18.7.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests 8.00.18.0.050098/79 5 others Atlas RPR Carbon Antigen Reagent, 5 ml/Vial, 1 Vial/Box. 8.00.18.2.000598/79 Atlas TPHA Kit, 100 Tests 8.00.19.0.010098/79 Atlas TPHA Kit, 200 Tests 8.00.19.0.020098/79 Atlas VDRL Kit , 2500 Tests 8.00.20.0.250098/79 RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks). 8.00.18.2.010098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Chronolab	Spain	RPR Carbon, 1 x 5 mL98/79 RPR Carbon, 250 tests98/79 RPR Carbon, 500 tests98/79 VDRL, 250 tests98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
Diagnostics	Belgium	RPR carbon 22152 - 22152-500 - 22152S98/79 RPR carbon 22152-500 - 22152 - 22152S98/79 RPR carbon 22152S - 22152 - 22152-50098/79	– 98/79	Website EUDAMED record Report an error
Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	RPR Non-Reactive Control GSD05-1600-NC RPR Reactive Control GSD05-1600-PC	C IVDR	Website EUDAMED record Report an error
LTA	Italy	Syphilis RPR 1x2 ml98/79 Syphilis RPR 2x5 ml98/79	– 98/79	Website office@ltaonline.it EUDAMED record Report an error
Newmarket Biomedical FDA EU representative : MDSS GmbH (Germany)	United Kingdom (ex Northern Ireland)	Newbio RPR 1002 refs PK7400 TP HA Controls98/79	C IVDR, 98/79	Website regulatory@new-bio.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Syphilis FIA98/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Diesse FDA	Italy	RPR-DAT ADVANCED RPRD-A	C IVDR	Website EUDAMED record Report an error
Linear FDA	Spain	Cromatest6 refs98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	RPR Carbon Positive Control Rapid Agglutination Syphilis Kits98/79	– 98/79	Website info@lornelabs.com EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	RPR CARBON3 refs98/79	– 98/79	Website EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	V.D.R.L. test4 refs98/79	– 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	RPR 100 tests - 5140198/79 (no longer marketed) TPHA 100 tests - 5190198/79 (no longer marketed) VDRL 100 tests - 5150198/79 (no longer marketed)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error

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