# Siemens Healthcare Diagnostics Inc. (manufacturer, E Walpole, MA): 5 new FDA device listings, incl. test, prostate specific antigen, free, (noncomplexed) to distinguish p

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Diagnostics Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | E Walpole, MA, US |
| New listings | 5 |
| Devices | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Carcinoembryonic Antigen; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| Product codes | MTG, NIG, JJX, DHX, LTK |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Immunology, Clinical Chemistry |
| Brand names | Atellica IM free PSA II (fPSAII); Atellica IM CA 19-9 II (CA 19-9 II); ADVIA Centaur Carcinoembryonic Antigen (CEA); Atellica IM Carcinoembryonic Antigen (CEA); Atellica IM CA 125II (CA 125II); ADVIA Centaur CA 125II (CA 125II) |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 1219913 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- 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.