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Sign in to claim this brandAggredyne, Inc.
US
Last updated May 27, 2026
What Aggredyne, Inc. makes
Aggredyne, Inc. manufactures in vitro diagnostic (IVD) reagents and automated analysers designed for platelet aggregation studies. Their products include reagents like the AggreDYNE AA Assay and the AggreGuide A-100 ADP, as well as the AggreGuide A-100 Instrument, which automates testing procedures. These tools are used to evaluate platelet function and reactivity in laboratory settings.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) and Unique Device Identification (UDI) systems. These devices are listed in the US regulatory framework, ensuring compliance with federal requirements for in vitro diagnostics. Aggredyne, Inc. is based in 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 Aggredyne, Inc. manufacture?
Aggredyne, Inc. specializes in in vitro diagnostic (IVD) devices used for platelet aggregation studies. Their products include both reagent kits, such as the AggreDYNE AA Assay and AggreGuide A-100 ADP, and automated analysers like the AggreGuide A-100 Instrument. These tools are designed to assess platelet function and reactivity in clinical or research laboratory settings.
Where is Aggredyne, Inc. based, and what regulatory framework applies to its devices?
Aggredyne, Inc. is headquartered in the United States. The company’s devices fall under the FDA’s regulatory oversight, specifically classified as Class II medical devices. This classification requires compliance with the FDA’s 510(k) premarket notification process and the Unique Device Identification (UDI) system, ensuring traceability and adherence to federal IVD standards.
Which regulatory registries or databases list Aggredyne, Inc.’s devices?
Aggredyne, Inc.’s devices are included in the FDA’s regulatory registries, specifically the 510(k) database and the Unique Device Identification (UDI) system. These listings reflect compliance with FDA requirements for Class II in vitro diagnostics, ensuring transparency and accessibility for healthcare providers and regulatory authorities.
How are Aggredyne, Inc.’s devices classified under FDA regulations?
Aggredyne, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to moderate-risk medical devices that require special controls to ensure their safety and effectiveness. Class II devices undergo a 510(k) premarket submission to demonstrate substantial equivalence to a predicate device, ensuring they meet regulatory standards before commercial distribution.
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
- 078703793
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aggreguide | A-100 | FDA UDI | Class II | Active |
| AggreDYNE AA Assay | A-100 | FDA UDI | Class II | Active |
| Aggreguide | A-100 | FDA UDI | Class II | Active |
| AggreGuide A-100 ADP | K181777 | FDA 510(k) | Class II | Active |
| AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | K163274 | FDA 510(k) | Class II | Active |
| Aggreguide | K122162 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Aggredyne, Inc. has one FDA recall record initiated on 2019-07-23, which is marked as completed. The recall was due to a software design issue in version 5.1, where improper shutdown of the instrument erased the speeds.csv file, resulting in incorrect target RPM settings and motor output values.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 23, 2019 | Z-1639-2022 | — | completed | The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0. Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low. |