Lactate Dehydrogenase (Ld)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935175 ↗

FDA Product Code

CFJ

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Systemate (Tm) Alanine Transferase (Alt)

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• Systemate Ldh, 67210

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  FDA 510(k) K843269 Active Cleared 13 Sep 1984

See all devices from Em Diagnostic Systems, Inc. →

• What clinical conditions does the Lactate Dehydrogenase (LD) Test help diagnose or monitor?

  The LD Test measures lactate dehydrogenase enzyme activity, which is elevated in conditions involving tissue damage or metabolic stress. Clinically, it aids in diagnosing myocardial infarction (heart attack), hemolytic anemia (red blood cell destruction), and liver disease (e.g., hepatitis or cirrhosis). Elevated LD levels can also indicate muscle damage or certain cancers. The test provides quantitative results to support clinical decision-making in these scenarios.

• How is the Lactate Dehydrogenase (LD) Test supplied, and is it single-use?

  The LD Test is supplied as a reagent kit designed for use in clinical chemistry laboratories. It is intended for single-use only, adhering to standard laboratory practices for in vitro diagnostics. Each kit contains the necessary reagents to perform one test, ensuring consistency and preventing cross-contamination between samples.

• Does the Lactate Dehydrogenase (LD) Test require special storage conditions?

  While the specific storage instructions are not detailed in the provided data, reagent kits like the LD Test typically require protection from extreme temperatures, light exposure, and moisture. Most clinical chemistry reagents are stored refrigerated (2–8°C) until use, with some components requiring additional handling (e.g., freezing). Always refer to the included instructions or manufacturer guidelines for precise storage protocols to maintain test accuracy.

• Is sterility or MRI safety information provided for the Lactate Dehydrogenase (LD) Test?

  The provided data does not include explicit information regarding sterility or MRI safety for the LD Test. As a reagent kit for in vitro diagnostic use, sterility is generally ensured through manufacturing controls, but clinicians should confirm any additional handling requirements (e.g., aseptic technique) with the manufacturer. Since the test is non-implantable and non-invasive, MRI safety is not applicable.

• What type of laboratory instrumentation is needed to perform the Lactate Dehydrogenase (LD) Test?

  The LD Test is designed for use in clinical chemistry laboratories equipped with standard instrumentation capable of Nad Reduction/Nadh Oxidation assays. This typically includes spectrophotometers or similar devices that measure enzymatic activity by detecting changes in absorbance. The test adheres to regulatory standards for in vitro diagnostics, ensuring compatibility with widely used laboratory systems.