FDA Registration
Active
🇨🇦 Canada
Rapid Response Drugs of Abuse Test Strip (Urine)
Reg #: 3003917514
·
FEI: 3003917514
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- BTNX Inc.
- Registration Number
- 3003917514
- FEI Number
- 3003917514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 722 Rosebank Road
- City
- Pickering Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K121065
Owner / Operator
- Firm Name
- BTNX Inc.
- Operator Number
- 9058575
- Address
- 722 Rosebank Road
- City
- PICKERING
- State
- Ontario
- Postal Code
- L1W 4B2
- Country
- CA
- Correspondent
- Iqbal Sunderani
US Agent
- Business Name
- Phil Triolo and Associates LC
- Contact Name
- Phil Triolo
- Address
- 86 Skycrest Lane
- City
- Emigration Canyon
- State
- UT
- ZIP
- 84108
- Country
- US
- [email protected]
- Phone
- 801 6999846
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2014-03-25 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2014-03-25 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2014-03-25 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2014-03-25 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2014-03-25 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2014-03-25 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2014-03-25 |
Proprietary Names
Rapid Response Drugs of Abuse Test Strip (Urine)
Rapid Response Drugs of Abuse Multi-Drug Test Panel (Urine)
Establishment Types
Foreign Private Label Distributor
Repack or Relabel Medical Device