Verified Nov 2026
Other
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Milan, Lombardy
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Since 1983
Sentinel Diagnostics is an independent Italian manufacturer of in vitro diagnostic (IVD) assays, headquartered in Milan, Lombardy. Founded in 1983, it employs an estimated 200-500 people with estimated annual revenue of $50-100M. The company serves clinical chemistry, molecular biology, immunology, and haemostasis, and supplies automated analyzer manufacturers, diagnostic companies, laboratories, and hospitals. Its Fecal Immunochemical Test (FIT) kits for colorectal cancer screening are a product line it promotes, and its products are reported to be used in more than 70 countries. The company is privately held.
Sentinel Diagnostics at a glance
Revenue
$50-100M
Est. band
Employees
200-500
Founded
1983
Headquarters
Milan, Lombardy
Certifications
ISO 13485 · ISO 14001 · ISO 45001 · ISO 9001
Industries
Automotive
Electric Vehicles
Medical
Industrial Equipment
STABILITY SIGNALS
Established & active
43 years in operation (founded 1983).
Holds ISO 13485, ISO 14001, ISO 45001, ISO 9001 certification(s) per public sources.
Overview
Sentinel Diagnostics is an independent Italian manufacturer of in vitro diagnostic (IVD) assays, headquartered in Milan, Lombardy. Founded in 1983, it employs an estimated 200-500 people with estimated annual revenue of $50-100M. The company serves clinical chemistry, molecular biology, immunology, and haemostasis, and supplies automated analyzer manufacturers, diagnostic companies, laboratories, and hospitals. Its Fecal Immunochemical Test (FIT) kits for colorectal cancer screening are a product line it promotes, and its products are reported to be used in more than 70 countries. The company is privately held.
At a glance
Attribute | Detail |
|---|---|
Founded | 1983 |
Headquarters | Milan, Lombardy |
Employees | 200-500 |
Revenue | $50-100M (estimated) |
Certifications | ISO 13485 · ISO 14001 · ISO 45001 · ISO 9001 |
What Sentinel Diagnostics makes
The company holds ISO 9001, ISO 13485, ISO 14001, and ISO 45001 certifications and reports acquiring the Eureka Lab Division to expand its chromatography and mass spectrometry capabilities.
Certifications
Sentinel Diagnostics is associated with the following certifications in public sources. Confirm the certified scope for the specific plant producing your part:
ISO 13485 — sentineldiagnostics.com
ISO 14001 — sentineldiagnostics.com
ISO 45001 — sentineldiagnostics.com
ISO 9001 — sentineldiagnostics.com
Latest developments
2026-02-27 — Threshold Harmonization and Clinical Performance in CRC Screening - Sentinel Diagnostics (sentineldiagnostics.com)
2026-02-17 — Sentinel Group at AMCLI 2026: Integrated Diagnostic Solutions for Immunocompromised Patients - Sentinel Diagnostics % (sentineldiagnostics.com)
2026-02-17 — Company Archives - Sentinel Diagnostics (sentineldiagnostics.com)
2025-12-16 — Sentinel Diagnostics Group at WHX Labs Dubai 2026: towards a global horizon in diagnostics - Sentinel Diagnostics % (sentineldiagnostics.com)
2025-11-18 — Sentinel Group Presents Full Diagnostic Portfolio at MEDICA 2025 - Medica 2025 - Labmedica.com (labmedica.com)
2025-10-24 — Sentinel Diagnostics at GISCoR 2025: new solutions for gastrointestinal diagnostics - Sentinel Diagnostics % (sentineldiagnostics.com)
Facilities
Sentinel Diagnostics is headquartered in Milan, Lombardy. Public sources also reference these locations:
Milan, Italy — amerigoscientific.com
Company details
The company operates as a business-to-business supplier to analyzer manufacturers and diagnostic companies and is reported to be the first IVD manufacturer in Italy. Sentinel Diagnostics was founded in 1983, has an estimated 200-500 employees, and is headquartered in Milan, Lombardy. On the LightSource stability read it is rated "Established & active": 43 years in operation (founded 1983). Holds ISO 13485, ISO 14001, ISO 45001, ISO 9001 certification(s) per public sources.
Frequently asked questions
What does Sentinel Diagnostics do?
Sentinel Diagnostics is an independent Italian manufacturer of in vitro diagnostic (IVD) assays, headquartered in Milan, Lombardy. Founded in 1983, it employs an estimated 200-500 people with estimated annual revenue of $50-100M. The company serves clinical chemistry, molecular biology, immunology, and haemostasis, and supplies automated analyzer manufacturers, diagnostic companies, laboratories, and hospitals. Its Fecal Immunochemical Test (FIT) kits for colorectal cancer screening are a product line it promotes, and its products are reported to be used in more than 70 countries. The company is privately held.
Where is Sentinel Diagnostics headquartered?
Sentinel Diagnostics is headquartered in Milan, Lombardy (2 Via Robert Koch, Milan, Lombardy, 20152).
When was Sentinel Diagnostics founded?
Sentinel Diagnostics was founded in 1983.
How big is Sentinel Diagnostics?
Sentinel Diagnostics has an estimated 200-500 employees, with revenue in the $50-100M range (estimated).
What certifications does Sentinel Diagnostics hold?
Sentinel Diagnostics lists ISO 13485 · ISO 14001 · ISO 45001 · ISO 9001 on its website. Confirm the certified scope for the specific plant producing your part.
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Last verified Nov 2026. Is this your company? Request a correction.
Location & contact
Phone
+39 02 345 5141
Certification
ISO 13485 · ISO 14001 · ISO 45001 · ISO 9001
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