FDA Registration
Active
🇦🇺 Australia
DOA Urine Cup
Reg #: 3031697086
·
FEI: 3031697086
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
1
Classifications
11
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
- K201630
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2025-05-06 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2025-05-06 |
Proprietary Names
DOA Urine Cup
Multi-Drug Urine Test Panel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)