# Siemens Healthcare Diagnostics Inc. (manufacturer, Newark, DE): 3 new FDA device listings, incl. bilirubin (total and unbound) in the neonate test system

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Diagnostics Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Newark, DE, US |
| New listings | 3 |
| Devices | Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; Colorimetry, Acetaminophen |
| Product codes | MQM, CIG, LDP |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Clinical Toxicology |
| Brand names | Atellica CH Diazo Total Bilirubin (D_TBil); Atellica CH Acetaminophen 2 (ACTMC); Atellica CH Acetaminophen 2 (ACTM) |
| First new listing | 2026-06-12 |
| Latest new listing | 2026-08-24 |
| FDA registration number | 2517506 |
| 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.