ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)
Streptococci
EMDN code W01050111
Manufacturers registered in Europe (EUDAMED) 74
- 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.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 62
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| HARDY DIAGNOSTICS | United States | StrepPRO™ HardyDisk™ OxiSticks™ OxiStrips™ BlueMount™ | K961191 (1996) |
| bioMerieux, Inc. Present in Europe in other categories | United States | API® NaCl 0.85% Medium RAPID ID 32 STREP ZYM B ZYM A VP A + VP B TDA | registered |
| PRO-LAB, INCORPORATED Present in Europe in other categories | Canada | Prolex Streptococcal Grouping Reagent Latex Suspension Group B Prolex Streptococcal Grouping Reagent Extraction Reagent 1 Prolex Streptococcal Grouping Latex Kit Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml) Prolex Streptococcal Grouping Reagent Latex Suspension Group A Prolex Streptococcal Grouping Reagent Latex Suspension Group D | K934383 (1995) |
| Quidel Corp. | United States | QuickVue QuickVue In-Line Sofia QuickVue+ | K171976 (2017) |
| AnalytiChem USA, Inc. | United States | Redipor | registered |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | OSOM Ultra Strep A 5 Test Kit OSOM Ultra Strep A 25 Test Kit OSOM Ultra Strep A 50 Test Kit OSOM Strep A 10 Test Kit STREP A, MERIDIAN IMMUNO 50 Test Kit OSOM Strep A 50 Test Kit | registered |
| Alere Scarborough, Inc. | United States | BinaxNOW Strep A Card BinaxNOW Strep A Control Swab Pack BinaxNOW Streptococcus pneumoniae Antigen Card BinaxNOW Streptococcus pneumoniae Control Swab Pack | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Microbiologics, Inc. Present in Europe in other categories | United States | Test Kits Chemmette Reagents General Reagents | K970009 (1997) |
| Mkl Diagnostics AB | – | Phadebact Strep Positive Controls Phadebact Strep D Test Phadebact Strep F Test Phadebact CSF Positive Controls Phadebact Pneumococcus Test | registered |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Present in Europe in other categories | China | Group B Streptococcus Detection Kit(Immunochromatography) Group A Streptococcus Antigen Detection Kit (Immunochromatography) | registered |
| Alere San Diego, Inc. Present in Europe in other categories | United States | Signify® Acceava® Clearview® | registered |
| Anaerobe Systems | United States | Esculin Reagent - 1% Ferric Ammonium Citrate Indole Reagent - p-Dimethylaminocinnamaldehyde Anaerobic Catalase Reagent - 15% Hydrogen Peroxide | K844383 (1985) |
| BTNX Inc | – | Rapid Response | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| GERMAINE LABORATORIES, INC | United States | STREPAIM | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Nihon Kohden America, Inc. Present in Europe in other categories | United States | Nihon Kohden, EEG-1200A Series Neurofax | registered |
| Rebound Therapeutics | United States | AURORA® Surgiscope® | registered |
| ACON Laboratories, Inc. | United States | Flowflex Plus Strep A Rapid Test Cassette Flowflex Plus Strep A Rapid Test Strip | K251697 (2025) |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Icon | registered |
| EASY HEALTHCARE CORPORATION | – | Areta Strep A Swab Test Strip (25 tests kit) | registered |
| Fisher Scientific Co., LLC | United States | Sure-Vue | registered |
| Polymedco, Inc. | United States | Poly stat | registered |
| STANBIO LABORATORY, L.P. | United States | QuSTICK™ Strep A | registered |
| ALERE NORTH AMERICA, LLC | – | Wampole ColorCard® Streptozyme® | registered |
| DEALMED MEDICAL SUPPLIES LLC | – | Dealmed | registered |
| ELITECH MICROBIO Present in Europe in other categories | – | MYCOFAST US | registered |
| Immunostics Company, Inc | United States | Detector Strep A | registered |
| JANT PHARMACAL CORPORATION | – | Accutest Value+ Strep A Rapid Test Strip | registered |
| KOROS U.S.A., INC. | United States | Multi Level Black Belt Instrument Tray | registered |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | PRO ADVANTAGE | registered |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | – | registered |
| ALFA SCIENTIFIC DESIGNS, INC. | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | K971522 (1998) |
| BioSquare Inc. | South Korea | – | registered |
| Biolog Inc | United States | – | registered |
| CTK BIOTECH, INC. Present in Europe in other categories | United States | – | registered |
| Changchun Lyz Technology Co., Ltd. | China | – | registered |
| DIAsource ImmunoAssays, SA | Belgium | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| ELITECHGROUP INC. Present in Europe in other categories | United States | – | registered |
| ESI Manufacturing, LLC | United States | – | registered |
| Ethos Biosciences | United States | – | registered |
| Fresh Valley | Pakistan | – | registered |
| HONG KONG MEDSOURCING LIMITED | Hong Kong SAR China | – | registered |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | – | registered |
| JAMES ALEXANDER CORP. | United States | – | registered |
| Jinan Babio Biotechnology Co., Ltd. | China | – | registered |
| KEY SCIENTIFIC PRODUCTS | United States | – | registered |
| MAST GROUP LIMITED Present in Europe in other categories | United Kingdom | – | registered |
| MEDICON HELLAS SA Present in Europe in other categories | Greece | – | registered |
| Medical Wire & Equipment Co. | United States | – | registered |
| Panion & BF Biotech, Inc. | Taiwan | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| RR Donnelley Global Turnkey Solutions | United States | – | registered |
| STS Corporation | United States | – | registered |
| Sa Scientific, Inc. | United States | – | K023270 (2002) |
| Sanicure BV | Netherlands | – | registered |
| Scantibodies Laboratory Inc. | United States | – | registered |
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