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Drew Scientific , Ltd.

US

Last updated May 23, 2026

What Drew Scientific , Ltd. makes

Drew Scientific, Ltd. manufactures in vitro diagnostic (IVD) controls, kits, and reagents for clinical chemistry testing, including total lipoprotein, HDL cholesterol (via mass spectrometry), urea, creatinine, uric acid, glucose/ketone/lipid profiles, triglycerides, and total cholesterol. Their products are designed for laboratory use, employing methods such as enzyme spectrophotometry, chemiluminescent immunoassay, and rapid testing.

The company’s portfolio is regulated under FDA Class I and Class II devices, with submissions recorded in the FDA’s 510(k) and UDI registries. Drew Scientific, Ltd. 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

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US
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Catalogue (259)

Page 6 of 6
DeviceModel / ReferenceRegistriesClassStatus
745 Glycomat K933287
FDA 510(k)
Class IIActive
D3 Hematology Analyzer, Model D3 K071562
FDA 510(k)
Class IIActive
Glycomat Green Hba2 Estimation Reagent Kit K924496
FDA 510(k)
Class IIActive
Drew Scientific Glycated Hemoglobin Five Level Linearity Kit K060510
FDA 510(k)
Class IActive
Trilogy Analyzer K070704
FDA 510(k)
Class IIActive
Glycomat Haemoglobin Analyser K920198
FDA 510(k)
Class IIActive
Ds30 Hcy Blood Collection Tubes K012152
FDA 510(k)
Class IIActive
Ds30 Hcy Homocysteine Assay Kit K982003
FDA 510(k)
Class IIActive
Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit K043378
FDA 510(k)
Class IIActive

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