7 devices · 7 companies · 2013 to 2026
AI-enabled microbiology devices on FDA's list
7 devices in the Microbiology panel, 2013 to 2026, from 7 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Microbiology panel
- PPU · Microbial Colony Image Assessment System2
- PEX · System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2
- PRE · Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers1
- PRH · Positive Blood Culture Identification And Ast Kit1
- OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay1
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| PhenoMATRIXK251511 · 510(k) | Copan Wasp Srl | PPU | database entry | |
| TriVerityK241676 · 510(k) | Inflammatix, Inc. | PRE | database entry | |
| Accelerate Pheno System, Accelerate PhenoTest BCK192665 · 510(k) | Accelerate Diagnostics, Inc. | PRH | database entry | |
| APAS Independence with Urine Analysis ModuleK183648 · 510(k) | Clever Culture Systems AG | PPU | database entry | |
| FluChip-8G Influenza A+B AssayK182513 · 510(k) | InDevR, Inc. | OZE | database entry | |
| MALDI BIOTYPER CAK130831 · 510(k) | BRUKER DALTONICS, INC | PEX | database entry | |
| VITEK MSDEN130013 · De Novo | BIOMERIEUX, INC. | PEX | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.