# Tecan Cdmo Solutions Mh, Corp. (contract manufacturer, Morgan Hill, CA): 3 new FDA device listings, incl. deformability cytometry for sepsis risk assessment

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Tecan Cdmo Solutions Mh, Corp. |
| Owner / operator | Tecan Group AG |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Morgan Hill, CA, US |
| New listings | 3 |
| Devices | Deformability Cytometry For Sepsis Risk Assessment |
| Product codes | QUT |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | IntelliSep test |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-13 |
| FDA registration number | 3003537036 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.