SGOT Reagent Set

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

510(k) Number

K844322 ↗

FDA Product Code

CIQ

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Albumin Reagent Set

  Class II

  FDA 510(k) K843831 Active Cleared 11 Oct 1984

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  FDA 510(k) K844024 Active Cleared 30 Oct 1984

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  FDA 510(k) K843701 Active Cleared 1 Oct 1984

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  FDA 510(k) K844182 Active Cleared 9 Nov 1984

• Serum Iron/Vibc Reagent Set

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  FDA 510(k) K852161 Active Cleared 10 Jun 1985

See all devices from Livonia Diagnostics, Inc. →

• What is the SGOT Reagent Set used for in clinical settings?

  The SGOT Reagent Set is designed for clinical chemistry assays to measure serum glutamic oxaloacetic transaminase (SGOT), an enzyme found in the liver, heart, skeletal muscle, and kidneys. Elevated SGOT levels can indicate liver disease, heart conditions, or muscle disorders, making this reagent essential for diagnosing and monitoring these conditions in laboratory settings.

• How is the SGOT Reagent Set supplied and intended for use?

  The SGOT Reagent Set is supplied as a liquid formulation, specifically formulated for single-use in clinical laboratories. It is intended to be used once per assay, ensuring accuracy and consistency in SGOT measurements without carryover risks from reuse.

• Is the SGOT Reagent Set sterile and stable for its intended use?

  Yes, the SGOT Reagent Set is classified as sterile and stable for its intended application in clinical laboratory settings. This ensures reliability and safety when performing SGOT assays, as the manufacturer has validated its formulation to maintain integrity until use.

• What regulatory clearance does the SGOT Reagent Set hold?

  The SGOT Reagent Set has received FDA 510(k) clearance (K844322) as substantially equivalent to a predicate device. This clearance confirms its compliance with FDA regulations for Class II medical devices under the product code CIQ, ensuring it meets established safety and performance standards for clinical chemistry assays.

• Can this reagent set be used for other transaminase assays besides SGOT?

  The SGOT Reagent Set is specifically designed for measuring SGOT (serum glutamic oxaloacetic transaminase) and falls under the category of Diazo reagents for transaminase assays. While it may share some chemical principles with other transaminase assays, it is not intended for use with AST (aspartate transaminase) or other enzymes without explicit manufacturer validation or additional reagents.