Infectious diseasesInfectious immunology - rapid tests & point of careBacteriology - RT & POC

Strep. a - RT & POC

EMDN code W0105090103

68 manufacturers, 208 models including 207 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 68

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
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	berkeleyhealth Easy Check Strep A rapid test (Professional)98/79 Berkeleyhealth Easy Check Strep A rapid test cassette98/79 Cassette Test Rapide Strep A98/79 SCREEN® Strep A Test3 refs Strep A Rapid Test Cassette (Control Line in Blue)(Throat Swab)98/79 14 others Strep A Rapid Test Cassette (Control Line in Red) IST-50298/79 Strep A Rapid Test Cassette (Throat Swab)2 refs98/79 Strep A Rapid Test Cassette IST-50298/79 Strep A Rapid Test Cassette IST-N50298/79 Strep A Rapid Test Cassette IST-R50298/79 Strep A Rapid Test Cassette ISTB-50298/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick98/79 Strep A Rapid Test Dipstick (Throat Swab)98/79 Strep A Rapid Test IST-50198/79 Strep A Rapid Test IST-N5013 refs Strep A Rapid Test ISTB-N501-253 refs Strep A Test Cassette FI-STA-50298/79 Strep A Test Cassette(Swab)98/79	B, C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
nal von minden	Germany	dedicio® Strep A Test3 refs98/79 FUTURLAB® Strep A Test98/79 Hitado strep a2 refs98/79 Hitado strep a Test3 refs meditrol® Strep A Test98/79 7 others NADAL® Strep A Plus Test2 refs98/79 NADAL® Strep A Scan Test98/79 NADAL® Strep A Test8 refs NEO CITOSTREP® Strep A Test98/79 S-MedPro Strep A Test98/79 Secu® Strep A Test6 refs98/79 StrepA PreMax® Test2 refs98/79	B IVDR, 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Strep A Test ISA0198/79 Strep A Test ISA10198/79 Strep A Test RTSA0198/79 Strep A Test RTSA10198/79 Strep A Test TISA0101098/79 7 others Strep A Test TISA10198/79 Strep A Test TSA0198/79 Strep A Test TSA10198/79 Strep A Test, Eco TISA0198/79 Strep A Test, Plus TISA0114098/79 Strep A Test, Single TISA0120598/79 Strep A Test, Single TISA0122098/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 7 others Group A Streptococcus Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 Group A Streptococcus Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) and 2 others	Japan, South Korea, United States	BinaxNOW™ RSV Control Swab Kit (10 POS+10 NEG) 430-08098/79 BinaxNOW™ Strep A Control Swab Kit (5 POS+5 NEG) 730-01098/79 Bioline™ Strep A98/79 Bioline™ Strep A 45FK1298/79 ID NOW™ Strep A 2 (24T) 734-00098/79 2 others SD Bioline Strep A 45FK1298/79 TestPack Plus Strep A with OBC98/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	LYHER ISA-502-0198/79 LYHER ISA-502-0298/79 LYHER ISA-502-0598/79 LYHER ISA-502-0798/79 LYHER ISA-502-2098/79 2 others LYHER ISA-502-2598/79 LYHER ISA-502-4098/79	– 98/79	office@lyher.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Strep A Rapid Test Cassette (Throat Swab) GCSTR-501a-DR,GCSTR-501Ca-DR,GCSTR-502a-DR,GCSTR-502Ca-DR3 refs Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 2 others Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79	B IVDR, 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 1 other Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™5 refs RapidFor™ VMD150FD98/79 RapidFor™ VMD150SC98/79 RapidFor™ VMD36DTS98/79 RapidFor™ VMD36STS98/79 1 other WellFor Strep A v2.0 Test Kit VMD150ST0198/79	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Strep A FIA Test98/79 Strep A Test SW01-STA98/79 Strep A Test SW01B-STA98/79 Strep A Test SW02-STA98/79 Strep A Test SW02B-STA98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Strep A Rapid Test Cassette (Throat Swab)2 refs98/79 Strep A Rapid Test Cassette ISTB-R50298/79 Strep A Rapid Test Dipstick (Throat Swab)2 refs98/79 Strep A Test Cassette (Throat Swab)98/79 Strep ARapid Test Cassette (Control Linein Red)98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Strep A Rapid Test Cassette IST-50298/79 Strep A Test STA-5A198/79 Strep A Test STA-5C198/79 Strep A Test STAB-5A198/79 Strep A Test STAB-5C198/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Innovacon EU representative : MDSS GmbH (Germany)	United States	456482900098/79 456483900198/79 456484900198/79 456485900098/79 456487900198/79	– 98/79	EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Strep A Assay F11-STA01C598/79 Strep A Rapid Test L11-ST01A598/79 Strep A Rapid Test L11-ST01C598/79 Strep A Rapid Test L11-STB01A598/79 Strep A Rapid Test L11-STB01C598/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	Clearview™ Strep A Dipstick 2 IST-50198/79 Clearview™ Strep A Cassette 2 IST-50298/79 IST-50198/79 IST-50298/79	– 98/79	EUDAMED record Report an error
Singclean EU representative : SUNGO Europe B.V. (Netherlands)	China	Singclean Cassette：1 test/box98/79 Singclean Cassette：10 tests/box98/79 Singclean Cassette：20 tests/box98/79 Singclean Cassette：5 tests/box98/79	– 98/79	Website EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Strep A Rapid Test (Control Line in Blue)2 refs98/79 Strep A Rapid Test (Control Line in Red) I045-500198/79 Strep A Rapid Test (Control Line in Red) I045-500298/79 Strep A Test Kit YI051-500298/79	– 98/79	EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands)	China	Quick MASTER Strep A Test Kit (FIA) VID1072 refs98/79 Strep A Rapid Test VIST98/79 Strep A Rapid Test VIST-70198/79 Strep A Test VIST98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Widufit	Germany	STREP A Rapid Test WIB-SA-K98/79 STREP A Rapid Test WIB-SA-S98/79 WiduMed Strep A Kassettentest98/79 WiduMed Strep A Streifentest98/79	– 98/79	Website info@widufit.de EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Strep A plus Rapid Test GIST98/79 Strep A Rapid Test GIST98/79 Strep A Rapid Test GISTA-702H3 refs Strep A Rapid Test(Control Line in Red) GIST98/79	C IVDR, 98/79	info@vivachek.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : AR Experts B.V. (Netherlands) and 1 other	China	PreventID Strep A R34-11298/79 R34-11098/79 R34-11298/79	– 98/79	EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) and 1 other	China	Group A Streptococcus Antigen Test Kit Cassette Strip2 refs98/79 Group A Streptococcus Antigen Test Kit Strip98/79 Strep A Antigen Test Kit Cassette GAS1TST-13 refs	C IVDR, 98/79	sales@dbluemedical.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	STA FIA STA-S23F398/79 Strep A Rapid Test Device Strip, Device A46310113 refs Strep A Rapid Test STA-S2398/79	B IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ferrarihub98/79 RightSign3 refs RightSign Home+	B, C IVDR, 98/79	info@biotests.com.cn EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	Strep A Rapid Test Device -Throat Swab3 refs98/79 Strep A RTC Rapid Test Device – Throat Swab98/79 Strep A Test Device -Swab D-FISTRAS2098/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI IST-501 (Strip) / IST-502 (Device)98/79 QINGLI Strip: 25Test/Kit98/79 Strep A Rapid Test Device IST-502s	C IVDR, 98/79	EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® Strep A Cassette (Throat Swab)98/79 Accu-tell® Strep A Strip (Throat Swab)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Strep A Rapid Test Cassette (Control Line in Red) STA-2-G98/79 Strep A Rapid Test Dipstick (Control Line in Red)98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	BOIRON A10013001D98/79 Group A Streptococcus Test Kit A0216700298/79	– 98/79	info@anbio.com EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	Switzerland	BIOSYNEX Strep A98/79 BIOSYNEX Strep A BSX98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands)	China	Rapid Strep A Test Card 1O08C598/79 Rapid Strep A Test Card 1O08C5-198/79	– 98/79	Website EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain)	Canada	Strep A Rapid Test Cassette (Throat Swab)98/79 Strep A Rapid Test Cassette IST-502(CT)98/79	– 98/79	ra02@citestdiagnostics.com EUDAMED record Report an error
Dutch Diagnostics	Netherlands	Strep A Test3 refs98/79 TMS Strep A2 refs98/79	– 98/79	Website info@dutch-diagnostics.com EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit98/79 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	DIAGOTEC Strep A Rapid Test3 refs Sinocare Strep A FIA KIT98/79	C IVDR, 98/79	Website info@gensurebio.com EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Strep A Antigen Rapid Test Kit (Colloidal gold method) CR02398/79 Strep B Antigen Rapid Test Kit (Colloidal gold method) CR02998/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other	China	Strep A Rapid Test (Swab) STA-6011/STA-601298/79 Strep A Rapid Test Kit (swab) STA-6011/STA-601298/79	– 98/79	EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	TROD'ANGINE2 refs98/79	– 98/79	EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Flowflex98/79	– 98/79	Website EUDAMED record Report an error
Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Strep A Antigen Rapid Test STA-B02b98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Aidian FDA	Finland	QuikRead go Strep A98/79	– 98/79	Website eudamed@aidian.eu EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Strep A Rapid Test (Swab) ISA-101398/79	– 98/79	Website EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	EUDAMED record Report an error
Cesna	Türkiye	STREP HIZLI TEST KİTİ KONTROLÜ	B IVDR	Website info@cesna.com.tr EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain)	China	Strep A Rapid Tests ISAp001 ISAp002 ISAp00898/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	101A0202EY98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Strep A Antigen Rapid Test (Immunochromatography)98/79	– 98/79	Website EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Strep A Rapid Test Cassette/Strip HISTA-502/HISTA-50198/79	– 98/79	EUDAMED record Report an error
Jiangsu Medomics Medical Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Group A streptococcus Rapid test Kit98/79	– 98/79	Website info@medomics-dx.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain)	China	Strep A Antigen Test Kit R226T020B0C098/79	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Strep A Ag Test Kit Ir04498/79	– 98/79	EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN STP-S21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany)	China	Strep A antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Operon FDA	Spain	Simple / Stick Strep A 9.134.XXX.YY.ZZZ3 refs	B IVDR	Website infoeudamed@operon.es EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	Sofia Strep A+ FIA 25T98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Hong Kong SAR China	INDICAID™ Strep A Rapid Antigen Test98/79	– 98/79	Website info@phasesci.com EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany)	South Korea	Exdia Strep A98/79	– 98/79	Website info@precision-bio.com EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium)	Switzerland	GetTested STREP A TEST98/79	– 98/79	quality@primahometest.com EUDAMED record Report an error
Salofa FDA	Finland	Strep A test kit 75-75STREPA-xx98/79	– 98/79	Website info@salofa.com EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	Strep A Rapid Test98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany)	China	Strep A Antigen Rapid Test Kit (Colloidal gold method)98/79	– 98/79	sales@syngenebio.com EUDAMED record Report an error
Vircell	Spain	VIRAPID® STREPTOCOCCUS GROUP A Ag VRC003	B IVDR	EUDAMED record Report an error
Vitro FDA	Romania	Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse	B IVDR	Website office@vitro.ro EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	STREP A RAPID TEST KIT VISD024	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	One Step Strep A Swab Test3 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Strep A Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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