PEN — Gram-Negative Bacteria And Associated Resistance Markers Class II
Classification Details
- Product Code
- PEN
- Device Class
- Class II
- Regulation Number
- 866.3365
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243013 | luminex corporation | LIAISON PLEX Gram-Negative Blood Culture Assay | April 18, 2025 |
| K243759 | biofire diagnostics | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RF | December 20, 2024 |
| K213236 | genmark diagnostics, incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 27, 2022 |
| K193519 | biofire diagnostics | BioFire Blood Culture Identification 2 (BCID2) Panel | March 18, 2020 |
| K190341 | icubate | iC-GN iC-Cassette for use on the iC-System | June 28, 2019 |
| K182619 | genmark diagnostics, incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 12, 2019 |
| K181493 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) Panel | July 5, 2018 |
| K160457 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | March 15, 2016 |
| K143171 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2 | January 30, 2015 |
| K132843 | nanosphere | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | January 8, 2014 |
| K130914 | biofire diagnostics | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | June 21, 2013 |