Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGREAT LAKES DIAGNOSTICS, INC.
US
Last updated May 30, 2026
What GREAT LAKES DIAGNOSTICS, INC. makes
Great Lakes Diagnostics, Inc. produces in vitro diagnostic reagents and controls designed to detect and measure haemoglobin S (HbS), a key marker for sickle cell disease. Their products are used in laboratory settings to identify HbS levels in patient samples, supporting diagnostic testing for haemoglobinopathies. The portfolio includes both reagent kits and control materials to ensure accuracy in testing procedures.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use in the United States, adhering to applicable regulatory standards for in vitro diagnostics. No other regulatory listings or jurisdictions are specified for these products.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Great Lakes Diagnostics, Inc. manufacture?
Great Lakes Diagnostics, Inc. specializes in in vitro diagnostic (IVD) products focused on haemoglobin S (HbS) detection. Their portfolio includes reagents and controls specifically designed to identify and measure HbS levels in patient samples, which are critical for diagnosing sickle cell disease and other haemoglobinopathies. These products are intended for use in clinical laboratory settings to support accurate diagnostic testing.
Where is Great Lakes Diagnostics, Inc. based, and what regulatory jurisdictions do their devices operate in?
Great Lakes Diagnostics, Inc. is based in the United States. Their devices are currently listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with US regulatory requirements for in vitro diagnostics. The company’s products are intended for use within the US market, adhering to applicable US regulatory standards for Class II medical devices.
How are the devices manufactured by Great Lakes Diagnostics, Inc. classified under US regulations?
The devices produced by Great Lakes Diagnostics, Inc., such as their HbS reagents and controls, are classified as Class II medical devices under US regulations. This classification is based on their intended use in detecting and measuring haemoglobin S levels, which involves moderate risk due to their role in diagnosing serious conditions like sickle cell disease. Class II devices typically require special controls to ensure safety and effectiveness beyond general controls.
Which regulatory registries or databases list the devices made by Great Lakes Diagnostics, Inc.?
The devices manufactured by Great Lakes Diagnostics, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This database is a centralised repository for tracking medical devices authorised for use in the United States, ensuring transparency and traceability of device information for regulatory and market surveillance purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- greatlakesdiag.com
- —
- —
- [email protected]
- Phone
- 248.307.9494
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 804870996
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sickle-Heme | GLD-12 | FDA UDI | Class II | Active |
| Sickle-Heme | GLD-1 | FDA UDI | Class II | Active |
| Sickle-Heme | GLD-20 | FDA UDI | Class II | Active |
| Sickle-Heme | GLD-100 | FDA UDI | Class II | Active |
| Sickle-Heme | GLD-250 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.