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EUDAMED update: May 20, 2025
US-MF-000003311US-MF-000003311Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.
1 EU importer places this manufacturer's devices
SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →BioFire Diagnostics, LLC is a medical device manufacturer registered in EUDAMED. The company has 9 devices on the EU market across 30 countries. It holds 1 valid CE certificate. Headquartered in Salt Lake City, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 30 countries
Certificate IVDR 735494Rev. R002Manufacturer
BioFire Diagnostics, LLC
Notified body
BSI Group The Netherlands B.V.
2797Version
1
Valid from
7/23/2026
Valid until
5/6/2031
Showing 1–8 of 8 device families.
357302BUDI000020SG357302BUDI000006SN357302BUDI000005SL357302BUDI000917U8357302BUDI000001SC357302BUDI000004SJ357302BUDI002231TD357302BUDI000004SJShowing 1–9 of 9 devices.
| Product | Trade name | Reference / catalog number | Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary → | Quantity | Status |
|---|---|---|---|---|---|
| BioFire® Blood Culture Identification 2 (BCID2) Panel | BioFire® Blood Culture Identification 2 (BCID2) Panel | RFIT-ASY-0147 | 00815381020338 | 1 | On the market |
| BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel | BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel | 424803 | 00815381021007 | 1 | On the market |
| BioFire® Joint Infection (JI) Panel | BioFire® Joint Infection (JI) Panel | RFIT-ASY-0135 | 00815381020208 | 1 | On the market |
| FilmArray® 2.0 Instrument | FilmArray® 2.0 Instrument | FLM2-ASY-0001 | 00815381020031 | 1 | On the market |
| FilmArray® 2.0 Instrument | FilmArray® 2.0 Instrument | FLM2-ASY-0001 | 00815381020031 | 1 | On the market |
| FilmArray® Gastrointestinal (GI) Panel | FilmArray® Gastrointestinal (GI) Panel | RFIT-ASY-0104 | 00815381020116 | 1 | On the market |
| FilmArray® Meningitis/Encephalitis (ME) Panel | FilmArray® Meningitis/Encephalitis (ME) Panel | RFIT-ASY-0118 | 00815381020123 | 1 | On the market |
| FilmArray® Meningitis/Encephalitis (ME) Panel | FilmArray® Meningitis/Encephalitis (ME) Panel | RFIT-ASY-0119 | 00815381020130 | 1 | On the market |
| SpotFire® | SpotFire® | FAST-ASY-0002 | 00815381020369 | 1 | On the market |