QIAstat-Dx BCID GPF Plus AMR Panel— 510(k) K254194
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K254194 for QIAstat-Dx BCID GPF Plus AMR Panel, Substantially Equivalent on 2026-08-06. Applicant: QIAGEN GmbH. Device class: 2.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Code PAM
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Recent devices under product code PAM
view all- 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
More clearances from QIAGEN GmbH
view all- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250324 — QIAstat-Dx GI Panel 2 Mini B
- K243813 — QIAstat-Dx GI Panel 2 Mini B&V
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.