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Sign in to claim this brandWhat ZACROS CORPORATION makes
Zacros Corporation manufactures single-use assay containers and evacuated blood collection tubes for in vitro diagnostics (IVD), including anticoagulant tubes designed for blood sampling. Their portfolio also includes reagents and analysers for platelet aggregation studies, such as systems for thrombus formation analysis and disposable components like PL Chips and reservoir sets. These devices are intended for laboratory use in assessing platelet function and clot formation.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Their portfolio is primarily regulated in the United States, where these diagnostic tools are subject to compliance with FDA requirements for in vitro diagnostics.
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 Zacros Corporation manufacture?
Zacros Corporation specializes in in vitro diagnostic (IVD) devices, primarily single-use assay containers and evacuated blood collection tubes with anticoagulants. Their portfolio also includes reagents and analysers for platelet aggregation studies, such as systems like the T-TAS 01 Total Thrombus Formation Analysis System, as well as disposable components like PL Chips and reservoir sets. These devices are designed for laboratory use in assessing blood components like platelet function and clot formation.
Where is Zacros Corporation based, and where are its devices primarily regulated?
Zacros Corporation is based in the United States. Their devices are primarily regulated under FDA guidelines, specifically as Class II in vitro diagnostic products. This classification applies to their portfolio of diagnostic tools, which are subject to compliance with FDA requirements for IVDs in the US market.
Which regulatory registries or databases list Zacros Corporation’s devices?
Zacros Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II in vitro diagnostic products, ensuring transparency and compliance with regulatory standards in the United States.
How are Zacros Corporation’s devices classified under FDA regulations?
Zacros Corporation’s devices are classified as Class II medical devices under FDA regulations. This classification applies to their in vitro diagnostics, including assay containers, blood collection tubes, platelet aggregation reagents, and analysers. Class II devices typically require special controls to ensure their safety and effectiveness, beyond general controls.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 690584370
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| T-TAS 01 Total Thrombus Formation Analysis System | T-TAS 01-1 | FDA UDI | Class II | Active |
| PL Chip | N/A | FDA UDI | Class II | Active |
| BAPA tube for T-TAS 01 | N/A | FDA UDI | Class II | Active |
| PL Chip Reservoir Set for T-TAS 01 | N/A | FDA UDI | Class II | Active |
| PL Chip Reservoir Set | N/A | FDA UDI | Class II | Active |
| PL Chip for T-TAS 01 | N/A | FDA UDI | Class II | Active |
| BAPA tube | N/A | FDA UDI | Class II | Active |
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