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Sign in to claim this brandAIM LAB AUTOMATION TECHNOLOGIES PTY LTD
US
Last updated May 30, 2026
What AIM LAB AUTOMATION TECHNOLOGIES PTY LTD makes
The company produces automated specimen processing instruments designed for in vitro diagnostic (IVD) use, specifically the PATHFINDER series. These devices are intended for handling and preparing biological samples in clinical laboratory settings, supporting workflows such as sample preparation and processing for downstream testing.
The PATHFINDER instruments fall under FDA Class I regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, where these devices are subject to compliance with U.S. regulatory requirements for IVD medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AIM Lab Automation Technologies Pty Ltd manufacture?
AIM Lab Automation Technologies Pty Ltd specializes in automated specimen processing instruments classified as in vitro diagnostic (IVD) devices. Their primary product line, the PATHFINDER series, is designed to handle and prepare biological samples in clinical laboratories, streamlining workflows like sample preparation and processing for further diagnostic testing.
Where is AIM Lab Automation Technologies Pty Ltd based, and what regulatory framework applies to their devices?
The company is based in the United States. Since their devices are in vitro diagnostics (IVDs), they are subject to U.S. regulatory requirements, including compliance with FDA guidelines. The PATHFINDER instruments fall under FDA Class I classification, which typically involves less stringent regulatory oversight compared to higher-risk devices.
Are AIM Lab Automation Technologies Pty Ltd’s devices listed in any regulatory registries?
Yes, the company’s PATHFINDER series devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.
How are AIM Lab Automation Technologies Pty Ltd’s devices classified by regulatory authorities?
The PATHFINDER instruments are classified as FDA Class I devices. This classification is determined based on the device’s risk level—Class I devices are generally considered low-risk and may require fewer regulatory controls, though compliance with manufacturing and labeling standards remains mandatory.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aimlab.com
- —
- —
- [email protected]
- Phone
- +61738971600
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 745595413
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pathfinder | PS-U-A711 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A605 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1202 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1203 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1204 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1201 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1206 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1205 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1210 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1207 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A069 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A084 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A1208 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A070 | FDA UDI | Class I | Active |
| Pathfinder | PS-U-A710 | FDA UDI | Class I | Active |
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