FDA Registration
Active
🇦🇺 Australia
INNOVATION SCIENTIFIC PTY LTD
Reg #: 3031697086
·
FEI: 3031697086
·
Expires 2026
Products
23
Proprietary Names
3
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- INNOVATION SCIENTIFIC PTY LTD
- Registration Number
- 3031697086
- FEI Number
- 3031697086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7/16 Rob Place
- City
- Vineyard New South Wales
- Country
- AU
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
US Agent
- Business Name
- Assure Tech LLC
- Contact Name
- allen chen
- Address
- 1521 Concord Pike Ste 201
- City
- Wilmington
- State
- DE
- ZIP
- 19803
- Country
- US
- [email protected]
- Phone
- 202 8675908
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, Methamphetamine, Over The Counter | NGG | 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, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2025-05-04 |
| 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, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2025-05-06 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2025-05-06 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2025-05-06 |
Proprietary Names
DOA Urine Cup
Multi-Drug Urine Test Panel
Innochem
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198