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HEMOSURE INC.

US

Last updated May 23, 2026

What HEMOSURE INC. makes

The company manufactures in-vitro diagnostic (IVD) kits and controls for rapid immunochromatographic testing (ICT), primarily designed for clinical use. These include tests for drugs of abuse (such as morphine, methamphetamine, and amphetamines), faecal occult blood, and human chorionic gonadotropin (hCG). Control products are also produced to validate test performance.

The portfolio consists of Class I, Class II, and unclassified (U) devices, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, where these products are regulated under applicable US medical device laws.

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 Hemosure Inc. manufacture?

Hemosure Inc. specializes in in-vitro diagnostic (IVD) kits and controls designed for rapid immunochromatographic testing (ICT). Their products primarily include tests for detecting drugs of abuse (such as morphine, methamphetamine, and amphetamines), faecal occult blood, and human chorionic gonadotropin (hCG). These are mostly intended for clinical use, such as point-of-care or laboratory settings.

Where is Hemosure Inc. based, and how does that affect its devices?

Hemosure Inc. is based in the United States, where its devices are regulated under applicable US medical device laws. Being based in the US means their products comply with FDA requirements, including registration in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor their devices for regulatory purposes.

Which regulatory registries list Hemosure Inc.’s devices?

Hemosure Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for regulatory oversight, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices in circulation.

How are Hemosure Inc.’s devices classified under medical device regulations?

Hemosure Inc.’s devices fall into different regulatory classes: Class I (generally low-risk), Class II (moderate-risk with special controls), and unclassified (U) devices. The classification depends on factors like the device’s intended use, potential risks, and the level of regulatory scrutiny required to ensure safety and effectiveness.

What is the purpose of the control products manufactured by Hemosure Inc.?

Hemosure Inc. produces IVD control products to validate the performance of their rapid immunochromatographic tests. Controls are essential for ensuring test accuracy, as they help verify that the testing process is functioning correctly before clinical samples are analyzed, reducing the risk of false results.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
806777541

Catalogue (191)

Page 1 of 4
DeviceModel / ReferenceRegistriesClassStatus
First Sign® FSCW11024
FDA UDI
Class IIActive
First Sign® FSCDIP254
FDA UDI
Class IIActive
First Sign® FSCCUP-13124 W/AD
FDA UDI
Class IIActive
First Sign® FSCCUP-2974
FDA UDI
Class IIActive
First Sign® FSCCUP-3464
FDA UDI
UActive
First Sign® FSCWCO-25
FDA UDI
Class IIActive
First Sign® FSCDIP47104
FDA UDI
Class IIActive
First Sign® FSCCUP-14124
FDA UDI
Class IIActive
Hemosure® DUO-CM10
FDA UDI
Class IIActive
First Sign® D0115-TC01
FDA UDI
Class IActive
First Sign® FSCDIP3384
FDA UDI
Class IIActive
First Sign® FSCDIP564
FDA UDI
Class IIActive
First Sign® FSCDIP06144
FDA UDI
Class IIActive
First Sign® FSCCUP-264
FDA UDI
Class IIActive
Hemosure® T1-CK50US
FDA UDI
Class IIActive
Hemosure T1-CK30
FDA UDI
Class IIUnknown
First Sign® FSCDIP5054
FDA UDI
Class IIActive
First Sign® FSCW4254
FDA UDI
Class IIActive
First Sign® FSCDIP3104
FDA UDI
Class IIActive
First Sign® FSCW874
FDA UDI
Class IIActive
First Sign® FSCCUP-654
FDA UDI
Class IIActive
First Sign® FSCCUP-47104 W/AD
FDA UDI
Class IIActive
First Sign® FSCW4854
FDA UDI
Class IIActive
Ovultell® F5-OST20/2
FDA UDI
Class IIActive
Hemosure F2-TC01
FDA UDI
N/AUnknown
First Sign® FSCDIPAM-25
FDA UDI
Class IIActive
First Sign® FSCECOII-9124 W/AD
FDA UDI
Class IIActive
First Sign® FSCDIP154
FDA UDI
Class IIActive
First Sign® FSCDIP09134
FDA UDI
Class IIActive
First Sign® FSCECOII-3464
FDA UDI
Class IIActive
First Sign® FSCCUP-47104
FDA UDI
Class IIActive
First Sign® FSCCUP-6164
FDA UDI
Class IIActive
First Sign® FSCECOII-4254
FDA UDI
Class IIActive
First Sign® FSCCUP-9124 W/AD2
FDA UDI
Class IIActive
Hemosure® T1-TB100L
FDA UDI
Class IIActive
First Sign® FSCECOII-564
FDA UDI
Class IIActive
Hemosure® T1-TB50
FDA UDI
Class IIActive
First Sign® FSCDIP2974
FDA UDI
Class IIActive
First Sign® FSCECOII-47104 W/AD
FDA UDI
Class IIActive
First Sign® FSCW654
FDA UDI
Class IIActive
First Sign® FSCDIP1424
FDA UDI
Class IIActive
First Sign® FSCDIP1984
FDA UDI
Class IIActive
First Sign® FSCCUP-9124
FDA UDI
Class IIActive
First Sign® FSCW334
FDA UDI
Class IIActive
First Sign® FSCECOII-654
FDA UDI
Class IIActive
First Sign® FSCDIPMO-25
FDA UDI
Class IIActive
First Sign® FSCDIPBA-25
FDA UDI
Class IIActive
First Sign® FSCCUP-13124 W/AD7
FDA UDI
UActive
First Sign® FSCDIP11024
FDA UDI
Class IIActive
Hemosure® T1-CK10
FDA UDI
Class IIActive

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