Asserachrom TPA Test Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K971519 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the Asserachrom TPA Test Kit used for?

  The Asserachrom TPA Test Kit is used for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma by the sandwich method, intended for hematology applications.

• How is the Asserachrom TPA Test Kit supplied?

  The device is supplied as a test kit containing mouse monoclonal anti-tPA antibody coated on the inside wall of a plastic microwell for laboratory use.

• What is the regulatory status of the Asserachrom TPA Test Kit?

  The Asserachrom TPA Test Kit is regulated under FDA 510(k) clearance with product code GGP, having received traditional clearance on August 19, 1997.

• Is the Asserachrom TPA Test Kit single-use or reusable?

  The device is not specified as single-use or reusable in the provided information, so users should refer to the manufacturer's instructions for proper handling and disposal.