BTNX Inc
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BTNX Inc is a medical device manufacturer, with 187 devices listed in FDA GUDID and EUDAMED (FDA Class II, Class I and Unclassified) as of 13 Nov 2026.
- Devices
- 187
Registry facts
- Registries
- FDA GUDID 187
- EUDAMED 1
- Device classes
- FDA Class II 149
- FDA Class I 28
- FDA Unclassified 10
- Identifiers
- DUNS 251005005
What BTNX Inc makes
BTNX Inc manufactures in-vitro diagnostic (IVD) devices for clinical and home-use testing, including rapid test kits for drugs of abuse, urine glucose, protein, human chorionic gonadotropin (hCG), leukocytes, blood, and ketones. Their portfolio also includes a glucose monitoring system for personal use and saliva-based screening cups for drug testing. Most products are designed for rapid, point-of-care results using colorimetric or immunochromatographic technology.
The company’s devices are classified under FDA’s Class I and Class II regulations, with some falling under the non-significant risk (N) or unclassified (U) categories. All listed products appear in the FDA’s Unique Device Identifier (UDI) database, reflecting their regulatory authorisation in the United States.
Catalogue
Search and filter all 187 devicesShowing 1-50 of 187
Company details
- DUNS number
- 251005005
Frequently asked questions
How many devices does BTNX Inc have in the registry?
The registry currently lists 187 devices for BTNX Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list BTNX Inc's devices?
Among its 50 most recently registered devices, BTNX Inc has devices listed in FDA GUDID (50 devices).
What risk classes do BTNX Inc's devices fall under?
Among its 50 most recently registered devices, the classes recorded for BTNX Inc's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BTNX Inc in the registry?
The most recently registered devices listed for BTNX Inc include Rapid Response D6.6.3-1V, Rapid Response D10.32-1VF, Rapid Response D10.3-1VF and Rapid Response D5.75-1VF.