FDA Registration
Active
🇦🇺 Australia
Multi-Drug Urine Test Panel
Reg #: 3031697086
·
FEI: 3031697086
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- INNOVATION SCIENTIFIC PTY LTD
- Registration Number
- 3031697086
- FEI Number
- 3031697086
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7/16 Rob Place
- City
- Vineyard New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K170049
Owner / Operator
- Firm Name
- Innovation Scientific Pty Ltd
- Operator Number
- 10093347
- Address
- 7/16 Rob Place
- City
- Vineyard
- State
- New South Wales
- Postal Code
- 2765
- Country
- AU
- Correspondent
- Anne F Jones
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2025-05-06 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2025-05-06 |
Proprietary Names
Multi-Drug Urine Test Panel
DOA Urine Cup
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)