2 devices · 2 companies · 2019 to 2026
Product code PPU: Microbial Colony Image Assessment System
2 devices under product code PPU, 2019 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Microbial Colony Image Assessment System. 21 CFR 866.2190, Class II. A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| PhenoMATRIXK251511 · 510(k) | Copan Wasp Srl | Microbiology | database entry | |
| APAS Independence with Urine Analysis ModuleK183648 · 510(k) | Clever Culture Systems AG | Microbiology | database entry |
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