Panels › Microbiology › Product code PAM · Class 2
Gram-Positive Bacteria And Their Resistance Markers
Regulation 866.3365
1510(k)s in 12 months (7 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in PAM
| Company | 510(k)s | Recalls |
|---|---|---|
| Luminex Corporation | 1 | 6 |
| Nanosphere, Inc. | 2 | 2 |
| BioFire Diagnostics, Inc. | 0 | 2 |
| Great Basin Scientific, Inc. | 1 | 1 |
| Genmark Diagnostics, Incorporated | 1 | 0 |
| Icubate, Inc. | 1 | 0 |
| QIAGEN GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2026 | K254194 | QIAstat-Dx BCID GPF Plus AMR Panel QIAGEN GmbH, DE | PAM |
| Jun 6, 2025 | K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay Luminex Corporation | PAM |
| Dec 20, 2018 | K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel Genmark Diagnostics, Incorporated | PAM |
| Aug 8, 2017 | K163390 | iC-GPC Assay TM for use on the iC-SystemTM Icubate, Inc. | PAM |
| Mar 25, 2016 | K152470 | Great Basin Staph ID/R Blood Culture Panel Great Basin Scientific, Inc. | PAM |
| Sep 19, 2012 | K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST Nanosphere, Inc. | PAM |
| Jun 26, 2012 | DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) Nanosphere, Inc. | PAM |
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