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Sign in to claim this brandHEMOSURE 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
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- Website
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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 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| First Sign® | FSCCUP-254 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP13124 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP1664 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-04144 W/AD | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-2124 | FDA UDI | Class II | Active |
| First Sign® | FSCW354 | FDA UDI | Class II | Active |
| First Sign® | FSCECOII-874 | FDA UDI | Class II | Active |
| Hemosure® | T1-CM50 | FDA UDI | Class II | Unknown |
| First Sign® | FSCDIP7164 | FDA UDI | Class II | Active |
| First Sign® | FSCDIPMA-25 | FDA UDI | Class II | Active |
| First Sign® | FSCWAM-25 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP2534 | FDA UDI | Class II | Active |
| Hemosure® | T1-TB10 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-04144 W/AD2 | FDA UDI | Class II | Active |
| First Sign® | FSCECOII-1984 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-13124 W/AD8 | FDA UDI | U | Active |
| First Sign® | FSCW564 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-354 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP174 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP14124 | FDA UDI | Class II | Active |
| Hemosure® | CM5-IUH | FDA UDI | Class II | Active |
| First Sign® | FSCW264 | FDA UDI | Class II | Active |
| First Sign® | F1-ST25 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-09134 | FDA UDI | Class II | Active |
| First Sign® | FSCECOII-264 W/AD2 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP354 | FDA UDI | Class II | Active |
| First Sign® | FSCW3464 | FDA UDI | U | Active |
| First Sign® | FSCCUP-1104 | FDA UDI | Class II | Active |
| First Sign® | FSCECOII-354 | FDA UDI | Class II | Active |
| First Sign® | FSCW13124 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-36104 | FDA UDI | Class II | Active |
| First Sign® | FSCW36104 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP04144 | FDA UDI | Class II | Active |
| First Sign® | FSCDIP4254 | FDA UDI | Class II | Active |
| First Sign® | FSCDIPOX-25 | FDA UDI | Class II | Active |
| First Sign® | FSCCUP-47104 W/AD2 | FDA UDI | Class II | Active |
| First Sign | FSCDIP1464 | FDA UDI | Class II | Active |
| First Sign® | F1-CT25U | FDA UDI | Class II | Active |
| First Sign® | D0115-TC02 | FDA UDI | Class I | Active |
| First Sign® | FSCDIP12104 | FDA UDI | Class II | Active |
| First Sign® | FSCECOII-19124 | FDA UDI | Class II | Active |
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