FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
K Number: K252329
·
Decision Oct 22, 2025
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
13
Review Days
89
Basic Information
- Device Name
- QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- K Number
- K252329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- QIAGEN GmbH
- Date Received
- July 25, 2025
- Decision Date
- October 22, 2025
- Product Code
- PCH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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Other Clearances by QIAGEN GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | Mar 9, 2026 | Substantially Equivalent |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | Aug 27, 2025 | Substantially Equivalent |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | Feb 28, 2025 | Substantially Equivalent |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | Jan 8, 2025 | Substantially Equivalent |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | Oct 29, 2024 | Substantially Equivalent |
| K242353 | QIAstat-Dx Respiratory Panel Mini | Oct 25, 2024 | Substantially Equivalent |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | May 31, 2024 | Substantially Equivalent |
| K233100 | QIAstat-Dx® Respiratory Panel Plus | May 10, 2024 | Substantially Equivalent |
| K183597 | QIAstat-Dx Respiratory Panel | May 18, 2019 | Substantially Equivalent |
| K133936 | ARTUS C. DIFFICILE QS-RGQ MDX KIT | Apr 4, 2014 | Substantially Equivalent |