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INSTRUMENTATION LABORATORY COMPANY

United States·US-MF-000035586

Last updated September 17, 2026

What INSTRUMENTATION LABORATORY COMPANY makes

The company manufactures in vitro diagnostics (IVDs) for blood gas, haemoximetry, and electrolyte analysis, including point-of-care and laboratory kits, controls, and analysers. Products include coagulation analysers, factor VIII assays (chromogenic), D-dimer controls, and electrolyte controls. Analyser models support multiple analyte testing, such as blood gases, haematocrit, and ion-selective electrodes, with some designed for quality management (e.g., calibration validation products).

These devices are regulated under EU Class A, B, and C classifications and US FDA Class I and II, with listings in the EUDAQD (eudamed) and FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
180, Hartwell Road, Bedford, United States
LinkedIn
—
Facebook
—
Phone
+1 800 678 0710
PRRC Contact
Carol Marble
EUDAMED SRN
US-MF-000035586
FDA FEI Number
2431530
DUNS Number
557223252

Catalogue (901)

Page 19 of 19
DeviceModel / ReferenceRegistriesClassStatus
HemosIL Q.F.A. Thrombin (Bovine) 0020301700
EUDAMEDFDA UDI
Class BActive

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