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Sign in to claim this brandAble Diagnostics Inc
US
Last updated May 25, 2026
What Able Diagnostics Inc makes
Able Diagnostics Inc manufactures in vitro diagnostic (IVD) glucose testing kits that use electrometry for measurement, single-use blood lancets for skin puncture, and infrared thermometers designed for non-contact skin temperature assessment. Their product line also includes manual blood lancing devices intended for single-use applications in clinical and home settings.
The company’s devices are classified under FDA regulations as Class I and Class II, with relevant products listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States under applicable regulatory frameworks.
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 Able Diagnostics Inc manufacture?
Able Diagnostics Inc specializes in the production of glucose testing kits that utilize electrometry for measurement. Additionally, the company manufactures single-use blood lancets and manual lancing devices for skin puncture, as well as infrared thermometers designed for non-contact skin temperature assessment. These products are developed for both clinical and home use.
Where is Able Diagnostics Inc based?
Able Diagnostics Inc is based in the United States. This location is relevant because the company develops and distributes its medical devices for use within the United States market, adhering to the regulatory frameworks applicable to that region.
How are the devices from Able Diagnostics Inc classified and where can they be found?
The devices produced by Able Diagnostics Inc are classified as Class I and Class II medical devices under FDA regulations. You can verify the presence of these products in the FDA’s Unique Device Identifier (UDI) database, which serves as the official registry for identifying medical devices throughout their distribution and use.
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
- 080952036
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VivaGuard | VGL02 | FDA UDI | Class II | Active |
| VivaGuard Ino Smart | VGM04 | FDA UDI | Class II | Active |
| VivaGuard | VGD01 | FDA UDI | Class II | Active |
| VivaGuard Ino | VGM01 | FDA UDI | Class II | Active |
| VivaGuard Ino | VGM01 | FDA UDI | Class II | Active |
| VivaGuard | VGL01 | FDA UDI | Class II | Active |
| VivaGuard Ino | VGS01 | FDA UDI | Class II | Active |
| VivaGuard Ino | VGM01 | FDA UDI | Class II | Active |
| VivaGuard Ino Smart | VGM04 | FDA UDI | Class II | Active |
| VivaGuard | VGL01 | FDA UDI | Class II | Active |
| VivaGuard Ino | VGC01 | FDA UDI | Class I | Active |
| VivaGuard Ino | VGC01 | FDA UDI | Class I | Active |
| VivaGuard Ino | VGC01 | FDA UDI | Class I | Active |
| VivaGuard Ino | VGS01 | FDA UDI | Class II | Active |
| VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer | HA-650 | FDA UDI | Class II | Active |
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