FDA Product Code
FDA Product Code PEN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3365
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | 2026-09-24 | Traditional | PDF ↗ |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation | 2025-04-18 | Traditional | PDF ↗ |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC | 2024-12-20 | Special | PDF ↗ |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | 2022-04-27 | Traditional | PDF ↗ |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | 2020-03-18 | Traditional | PDF ↗ |
| K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | 2019-06-28 | Traditional | PDF ↗ |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | 2019-04-12 | Traditional | PDF ↗ |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018-07-05 | Special | PDF ↗ |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016-03-15 | Special | PDF ↗ |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015-01-30 | Traditional | PDF ↗ |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | Nanosphere, Inc. | 2014-01-08 | Traditional | PDF ↗ |
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | Biofire Diagnostics, Inc. | 2013-06-21 | Traditional | PDF ↗ |
Product code PEN · Class II · Microbiology. Data: openFDA.