FDA Registration
Active
🇨🇦 Canada
Healstone Accurate Drug of Abuse Urine Test Cup
Reg #: 3014301129
·
FEI: 3014301129
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- HEALSTONE BIOTECH INC.
- Registration Number
- 3014301129
- FEI Number
- 3014301129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit #650 - 655 West Kent Avenue North
- City
- Vancouver British Columbia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K221871
Owner / Operator
- Firm Name
- Healstone Biotech Inc.
- Operator Number
- 10056764
- Address
- Unit 650, 655 West Kent Ave. N.
- City
- Vancouver
- State
- British Columbia
- Postal Code
- V6P6T7
- Country
- CA
- Correspondent
- Chichi Liu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2022-08-31 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-08-31 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-08-31 |
Proprietary Names
Healstone Accurate Drug of Abuse Urine Test Cup
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198