Infectious diseasesBacteriology (infect. immunology/NAT)Staphylococci
Staphylococcal direct antigen detection
EMDN code W0105011201
Manufacturers registered in Europe (EUDAMED) 2
- 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 |
|---|---|---|---|---|
| Pro-Lab Diagnostics EU representative : Advena Limited (Malta) | Canada |
|
– 98/79 | Website support@pro-lab.com EUDAMED record Report an error |
| Bio-Rad FDA | France |
|
B IVDR | Website contact@bio-rad.com EUDAMED record Report an error |
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) 6
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 |
|---|---|---|---|
| PRO-LAB, INCORPORATED Present in Europe in other categories | Canada | Prolex Staph Kit (300 Tests) Prolex Latex Reagent Control Negative (Staph) Prolex Staph Kit (100 tests) Prolex Staph Xtra Latex Kit (300 tests) Prolex Staph Xtra Latex Kit (100 tests) Prolex Staph Positive Control | registered |
| HARDY DIAGNOSTICS | United States | StaphTEX™ | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD BBL™ Staphyloslide™ Latex Test Kit | registered |
| Oxoid U.S.A., Inc. Present in Europe in other categories | United States | SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests | K855233 (1986) |
| Remel Co. Present in Europe in other categories | United States | Staphaurex (400 test) Staphaurex (120 test) | registered |
| Princeton BioMeditech Corp. Present in Europe in other categories | United States | – | registered |
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