FDA Registration
Active
🇨🇦 Canada
BTNX Inc. Rapid Response U500 Urine Analyzer
Reg #: 3003917514
·
FEI: 3003917514
·
Expires 2025
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12
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
- K111221
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 |
|---|---|---|---|---|---|
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | NGJ | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2013-12-12 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2013-12-12 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2013-12-12 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2013-12-12 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-12-12 |
Proprietary Names
BTNX Inc. Rapid Response U500 Urine Analyzer
Establishment Types
Foreign Private Label Distributor
Repack or Relabel Medical Device