# Siemens Healthcare Diagnostics Inc. (specification developer, Tarrytown, NY): 9 new FDA device listings, incl. test, epithelial ovarian tumor-associated antigen (ca125)

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Diagnostics Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Tarrytown, NY, US |
| New listings | 9 |
| Devices | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); System, Test, Carcinoembryonic Antigen; Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Immunological, Antigen, Tumor; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Colorimetry, Acetaminophen |
| Product codes | LTK, DHX, MQM, CIG, NIG, JJX, MOI, MTG, LDP |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Immunology, Clinical Chemistry, Clinical Toxicology |
| Brand names | ADVIA Centaur CA 125II (CA 125II); Atellica IM CA 125II (CA 125II); Atellica IM Carcinoembryonic Antigen (CEA); ADVIA Centaur Carcinoembryonic Antigen (CEA); Atellica CH Diazo Total Bilirubin (D_TBil); Atellica IM CA 19-9 II (CA 19-9 II); IMMULITE 2000 BR-MA; Atellica IM free PSA II (fPSAII) |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 2432235 |
| Registration expires | 2027-12-31 |

## 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: 2026-11-04T21:52:36.524Z.
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.