Product code PAM— Microbiology
Great Basin Staph ID/R Blood Culture Panel
- Classification name
- Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.”
Market context for product code PAM
FDA has cleared devices under product code PAM between 2012 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2018
- 2017
- 2016
- 2012
Top applicants under product code PAM
Adverse events under product code PAM
product code PAM- Death
- 6
- Malfunction
- 598
- Total
- 604
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PAM
- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K163390 — iC-GPC Assay TM for use on the iC-SystemTM
- K152470 — Great Basin Staph ID/R Blood Culture Panel
- K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
- DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Data sourced from openFDA. This site is unofficial and independent of the FDA.