Wiener Lab Got (Ast) UV Aa Liquida

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

510(k) Number

K023551 ↗

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 Wiener Laboratories Saic →

• What clinical chemistry applications does the Wiener Lab GOT (AST) UV AA Líquida support?

  The Wiener Lab GOT (AST) UV AA Líquida is a quantitative in vitro diagnostic device specifically designed for measuring glutamic oxaloacetic transaminase (GOT, AST) levels in liquid samples. It utilizes ultraviolet absorbance (UV AA) technology to enable precise biochemical analysis, making it suitable for clinical chemistry applications in laboratory settings. This allows clinicians to assess liver function and detect potential abnormalities in enzyme levels.

• How is the Wiener Lab GOT (AST) UV AA Líquida supplied, and what are its usage requirements?

  This device is supplied as a liquid reagent system intended for single-use in laboratory environments. It is compatible with automated or semi-automated clinical chemistry analyzers. No additional sterilization beyond standard laboratory practices is required, as it is designed for one-time use in controlled settings. This ensures consistency and reduces the risk of contamination.

• Is the Wiener Lab GOT (AST) UV AA Líquida reusable, and what are the regulatory considerations?

  The Wiener Lab GOT (AST) UV AA Líquida is explicitly designed for single-use only, meaning each vial or bottle is intended to be used once before disposal. Regulatory clearance for this device was granted under the FDA’s 510(k) Traditional pathway, confirming it meets Class II medical device standards (regulation number: 862.1100). This pathway ensures the device adheres to rigorous safety and performance requirements for in vitro diagnostics.

• What types of analyzers can be used with the Wiener Lab GOT (AST) UV AA Líquida?

  The Wiener Lab GOT (AST) UV AA Líquida is engineered to function with automated or semi-automated clinical chemistry analyzers. These systems are commonly used in laboratories to process multiple samples efficiently while maintaining accuracy. The device’s compatibility with such analyzers ensures seamless integration into existing workflows for AST/GOT testing.

• Are there any special storage requirements for the Wiener Lab GOT (AST) UV AA Líquida?

  While the provided data does not specify exact storage conditions, liquid reagent systems like the Wiener Lab GOT (AST) UV AA Líquida typically require storage in a cool, dry place, protected from direct light and extreme temperatures. Always refer to the manufacturer’s instructions or accompanying documentation for precise storage guidelines to maintain reagent integrity and ensure accurate test results.