ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)
Other bacteriology - NA reagents
EMDN code W01050116
Manufacturers registered in Europe (EUDAMED) 44
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 11
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 |
|---|---|---|---|
| Bio-Rad Present in Europe in other categories | United States | Amplichek | K152679 (2016) |
| Mmqci | – | BioFire RP2.1/RP2.1plus Control Panel M441 FilmArray GI Control Panel M238 SPOTFIRE RSP Negative Control FilmArray Warrior Control Panel M290 SPOTFIRE RSP Pos & Neg Controls FilmArray BCID2 Control Panel M416 | registered |
| Microbiologics, Inc. Present in Europe in other categories | United States | QC Sets and Panels: Helix Elite™ | K190086 (2019) |
| Biofire Defense, LLC | United States | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BioFire® Global Fever Special Pathogens Panel BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane BioFire Warrior Panel Control Kit | K261475 (2026) |
| Streck Laboratories, Inc. Present in Europe in other categories | United States | MDx-Chex for BC-GN MDx-Chex for BCID2 MDx-Chex for BC-GP | K260041 (2026) |
| DIAGNOSTIC HYBRIDS, INC. | United States | Savanna | registered |
| Nuclein, LLC | United States | DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit DASH® Negative Control Swabs Kit | registered |
| Autonomous Medical Devices Incorporated | United States | – | registered |
| Maine Molecular Quality Controls, Inc. Present in Europe in other categories | United States | – | K263232 (2026) |
| QuidelOrtho Corporation | United States | – | registered |
| Zeptometrix Present in Europe in other categories | United States | – | K201403 (2022) |
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- Parent category : Bacteriology (infect. immunology/NAT)278 manufacturers