PAM — Gram-Positive Bacteria And Their Resistance Markers Class II
Classification Details
- Product Code
- PAM
- Device Class
- Class II
- Regulation Number
- 866.3365
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243490 | luminex corporation | LIAISON PLEX Gram-Positive Blood Culture Assay | June 6, 2025 |
| K181663 | genmark diagnostics, incorporated | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | December 20, 2018 |
| K163390 | icubate | iC-GPC Assay TM for use on the iC-SystemTM | August 8, 2017 |
| K152470 | great basin scientific | Great Basin Staph ID/R Blood Culture Panel | March 25, 2016 |
| K122514 | nanosphere | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | September 19, 2012 |
| DEN120014 | nanosphere | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | June 26, 2012 |