Gemeni AST-LTS Reagents

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

510(k) Number

K851267 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Electro-Nucleonics Laboratories, Inc. →

• What clinical applications are the Gemeni AST-LTS Reagents primarily used for in a laboratory setting?

  The Gemeni AST-LTS Reagents are designed for measuring aspartate aminotransferase (AST) and serum glutamic-oxaloacetic transaminase (SGOT) activity through NADH oxidation/reduction reactions. These measurements are critical for evaluating liver function and assessing cardiac markers in serum or plasma samples, making them useful for monitoring conditions like liver disease or cardiac injury.

• Are the Gemeni AST-LTS Reagents intended for single-use or repeated use in a clinical setting?

  The Gemeni AST-LTS Reagents are explicitly supplied as single-use reagents. This design ensures consistency and safety in clinical chemistry applications, as repeated use could compromise accuracy or introduce contamination risks.

• How is the regulatory status of the Gemeni AST-LTS Reagents determined, and what does this mean for users?

  The Gemeni AST-LTS Reagents hold an FDA 510(k) clearance (K851267) under regulation number 862.1100, classified as a Class II device. This means the product has been reviewed by the FDA and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for use in clinical chemistry applications.

• What type of instrumentation is required to use the Gemeni AST-LTS Reagents in a laboratory?

  The Gemeni AST-LTS Reagents are intended for use in clinical laboratories with appropriate instrumentation capable of performing NADH oxidation/NAD reduction assays. While the specific equipment isn’t detailed, standard clinical chemistry analyzers designed for AST/SGOT testing would be suitable.

• Are there any special storage instructions provided for the Gemeni AST-LTS Reagents?

  The provided data does not specify sterility or detailed storage conditions for the Gemeni AST-LTS Reagents. However, as with most diagnostic reagents, compliance with standard laboratory reagent handling protocols—such as protecting from light, extreme temperatures, and contamination—is implied to maintain accuracy and stability.