CK-NAC 2-VIAL Reagent W/Substrate Start

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K891470 ↗

FDA Product Code

CGS

FDA applicant

Trace Scientific , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Trace Scientific, Ltd. →

• What is the CK-NAC 2-Vial Reagent W/Substrate Start used for?

  This reagent is used for determining creatine kinase (CK) activity in human serum or plasma, which is important in diagnosing conditions such as myocardial infarction and muscle disorders in laboratory settings.

• How is the CK-NAC 2-Vial Reagent supplied and is it reusable?

  The reagent is supplied as a two-vial system and is intended for single-use in clinical laboratories. It should not be reused and should be stored according to the manufacturer's instructions.

• What is the regulatory status of the CK-NAC 2-Vial Reagent?

  The device has received FDA 510(k) clearance with product code CGS and is classified as a Class II medical device for clinical chemistry applications. It is not MRI compatible.

• What laboratory applications is this reagent suitable for?

  This reagent is specifically designed for clinical chemistry applications in laboratory settings to measure CK levels, which aids in diagnosing myocardial infarction and various muscle disorders.