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Sign in to claim this brandBTNX Inc
US
Last updated May 23, 2026
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. The manufacturer is based in the US.
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 BTNX Inc manufacture?
BTNX Inc specializes in in-vitro diagnostic (IVD) devices, primarily rapid test kits and systems for clinical and home-use applications. Their portfolio includes urine-based tests for glucose, protein, human chorionic gonadotropin (hCG), leukocytes, blood, and ketones, as well as drug-of-abuse screening kits (including saliva-based tests) and a glucose monitoring system for personal use. These devices are designed for quick, point-of-care results using colorimetric or immunochromatographic technology.
Where is BTNX Inc based, and what regulatory body oversees their devices?
BTNX Inc is based in the United States. Their devices are regulated by the FDA, with all listed products appearing in the FDA’s Unique Device Identifier (UDI) database. This reflects their regulatory authorisation for use in the US market under applicable FDA classifications.
How are BTNX Inc’s devices classified under FDA regulations?
BTNX Inc’s devices fall under FDA’s Class I and Class II regulatory categories. Some products are classified as non-significant risk (N) or unclassified (U), which determines the level of oversight and clearance requirements. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risk to patients.
Which regulatory registries or databases list BTNX Inc’s devices?
BTNX Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, transparency, and regulatory compliance. Listing in this database confirms the devices’ regulatory authorisation for commercial distribution in the US.
What distinguishes BTNX Inc’s rapid test kits from other similar products?
BTNX Inc’s rapid test kits are designed for clinical and home-use applications, focusing on quick, point-of-care results—typically within minutes. Many of their products use colorimetric or immunochromatographic technology for easy interpretation, such as urine-based tests for glucose, protein, or drug-of-abuse screening. The inclusion of saliva-based screening cups (e.g., the 6 Panel Saliva Test Cup) also sets them apart by offering an alternative sample type for drug testing, which may be preferred in certain settings for convenience or discretion.
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
- 251005005
Catalogue (170)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rapid Response | D10.14.1-1V | FDA UDI | Class II | Active |
| Rapid Response | OXY-1S27-100 | FDA UDI | Class II | Active |
| Rapid Response | D10.22-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | STA-15S25 | FDA UDI | Class I | Active |
| Rapid Response | D12.36-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | HCG-1C50 | FDA UDI | Class II | Active |
| Rapid Response | D12.1-1G29-25 | FDA UDI | Class II | Active |
| Rapid Response | FYL-1CAP156 | FDA UDI | Class II | Active |
| Rapid Response | D3.4-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | D10.3.1-1V | FDA UDI | Class II | Active |
| Rapid Response | COF-19CGHU2 | FDA UDI | Class II | Active |
| Rapid Response | D12.8.1-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | MON-13C15 | FDA UDI | Class II | Active |
| Rapid Response | HCG-1S100 | FDA UDI | Class II | Active |
| Rapid Response | D5.3-1G29-25 | FDA UDI | Class II | Active |
| Rapid Response | D6.1-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | D4.1-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | D5.1.1-2FC1E | FDA UDI | Class II | Active |
| Rapid Response | MOP-1C3-40 | FDA UDI | Class II | Active |
| Rapid Response 10 Panel Saliva Test Cup E/I Screening | D10.42-2FC1E | FDA UDI | Class II | Active |
| Rapid Response | MTD-1S3-100 | FDA UDI | Class II | Active |
| Rapid Response | U-KET-1S100 | FDA UDI | Class I | Active |
| Rapid Response | D7.17-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | HCG-1C25 | FDA UDI | Class II | Active |
| Rapid Response | D10.3-1V | FDA UDI | Class II | Active |
| Rapid Response | D14.5-1VF | FDA UDI | Class II | Active |
| Rapid Response | D5.1-1G29 | FDA UDI | Class II | Active |
| Rapid Response | BAR-1S3-100 | FDA UDI | Class II | Active |
| Rapid Response | D6.6.2-1V | FDA UDI | Class II | Active |
| Rapid Response 9 Panel Saliva Test Cup E/I Screening | D9.21-2FC1E | FDA UDI | Class II | Active |
| Rapid Response | D5.75-1VF | FDA UDI | Class II | Active |
| Rapid Response | D12.5-1T | FDA UDI | U | Active |
| Rapid Response | AUCT-1V1 | FDA UDI | Class I | Active |
| Rapid Response | BZO-1S3-100 | FDA UDI | Class II | Active |
| Rapid Response | HCG-1C50 | FDA UDI | Class II | Unknown |
| Rapid Response | 02MSK-50 | FDA UDI | Class I | Active |
| Rapid Response | OPI-1C26-40 | FDA UDI | Class II | Active |
| Rapid Response | COF-19CGHU1 | FDA UDI | Class II | Active |
| Rapid Response | BUP-1S5-100 | FDA UDI | Class II | Active |
| Rapid Response | D5.2-1V | FDA UDI | U | Active |
| Rapid Response | COV-13C25 | FDA UDI | N | Active |
| Rapid Response | D10.6-1G29-25 | FDA UDI | Class II | Active |
| Rapid Response | UA-500 | FDA UDI | Class I | Active |
| Rapid Response | D12.1-1P29-25 | FDA UDI | Class II | Active |
| Rapid Response | U4.1-1S100 | FDA UDI | Class I | Active |
| Rapid Response | D12.5.1-1V | FDA UDI | U | Active |
| Rapid Response | D10.11-1V | FDA UDI | Class II | Active |
| Rapid Response | RSV-19C20 | FDA UDI | Class I | Active |
| Rapid Response | D10.3-1G29-25 | FDA UDI | U | Active |
| Rapid Response | UTI-1S1 | FDA UDI | Class I | Active |
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