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Sign in to claim this brandCedarlane Corporation
US
Last updated May 23, 2026
What Cedarlane Corporation makes
Cedarlane Corporation manufactures in vitro diagnostic (IVD) reagents for complement testing, including standardised rabbit complement preparations used in immunological assays. It also produces density gradient separation reagents, such as Lympholyte-H, for isolating blood cells, and fluorescein-labelled aerolysin (FLAER) reagents for identifying specific cell types. These products are designed for laboratory use in clinical diagnostics and research applications.
The company’s IVD portfolio is classified under Class I devices in the US, indicating a low to moderate risk level. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance. The manufacturer operates from the United States.
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 Cedarlane Corporation manufacture?
Cedarlane Corporation specializes in in vitro diagnostic (IVD) reagents. Its primary products include standardised rabbit complement reagents for immunological assays, density gradient separation reagents like Lympholyte-H for isolating blood cells, and fluorescein-labelled aerolysin (FLAER) reagents used to identify specific cell types in laboratory settings. These devices are designed for clinical diagnostics and research applications.
Where is Cedarlane Corporation based?
Cedarlane Corporation is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are classified and listed under US regulatory frameworks.
Which regulatory registries list Cedarlane Corporation’s devices?
Cedarlane Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with US regulatory requirements, allowing healthcare providers and authorities to track and verify the devices.
How are Cedarlane Corporation’s devices classified under US regulations?
Cedarlane Corporation’s IVD devices are classified under Class I in the US. This classification is assigned based on risk assessment, where Class I devices pose a low to moderate risk to patients. Since these products are primarily reagents and reagents for laboratory use, they fall into this category due to their minimal risk profile when used as intended.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 243928822
Catalogue (63)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Standard Rabbit Complement | CL3003 | FDA UDI | Class I | Unknown |
| Augurex Life Sciences | 90-0005 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5015 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3115 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3120 | FDA UDI | Class I | Active |
| Augurex Life Sciences | 90-0020 | FDA UDI | Class I | Unknown |
| Flaer | FL1 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3003 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3002 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3115 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5015 | FDA UDI | Class I | Active |
| Augurex Life Sciences | 90-0031 | FDA UDI | Class I | Unknown |
| Flaer | FL2 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3025 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3050 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3120 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3010-10 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3002 | FDA UDI | Class I | Active |
| Augurex Life Sciences | 90-0009 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3010-10 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3113 | FDA UDI | Class I | Active |
| Augurex Life Sciences | 90-0013 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5020 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3112 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3010 | FDA UDI | Class I | Active |
| Low-Tox-H Rabbit Complement | CL3335 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5020 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5016 | FDA UDI | Class I | Active |
| Low-Tox-H Rabbit Complement | CL3310 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3010 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3113 | FDA UDI | Class I | Unknown |
| Low-Tox-H Rabbit Complement | CL3305 | FDA UDI | Class I | Active |
| Flaer | FL1 | FDA UDI | Class I | Active |
| Low-Tox-H Rabbit Complement | CL3305 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5010 | FDA UDI | Class I | Active |
| Flaer | FL2S | FDA UDI | Class I | Unknown |
| Low-Tox-H Rabbit Complement | CL3350 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3111 | FDA UDI | Class I | Unknown |
| Standard Rabbit Complement | CL3001 | FDA UDI | Class I | Active |
| Standard Rabbit Complement | CL3025 | FDA UDI | Class I | Unknown |
| Flaer | FL2S | FDA UDI | Class I | Active |
| Lympholyte-H | CL5010 | FDA UDI | Class I | Unknown |
| Low-Tox-H Rabbit Complement | CL3335 | FDA UDI | Class I | Active |
| Augurex Life Sciences | 90-0021 | FDA UDI | Class I | Unknown |
| Low-Tox-H Rabbit Complement | CL3350 | FDA UDI | Class I | Active |
| Flaer | FL2 | FDA UDI | Class I | Active |
| Standard Rabbit Complement, Frozen | CL3005 | FDA UDI | Class I | Unknown |
| Lympholyte-H | CL5016 | FDA UDI | Class I | Unknown |
| Low-Tox-H Rabbit Complement | CL3331 | FDA UDI | Class I | Active |
| Standard Rabbit Complement, Frozen | CL3005 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cedarlane Corporation BURLINGTON Ontario · CA FEI 3000178900