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Liquid AST (SGOT) Reagent Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K941132

by Pointe Scientific, Inc.

Identifiers

510(k) Number
K941132 FDA 510(k)
FDA Product Code
CIT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1100 FDA 510(k)
Regulation Number
862.1100 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Liquid AST (SGOT) Reagent Set is a clinical chemistry reagent set used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. This device is classified under the product code CIT and is intended for use in clinical laboratory settings to measure AST levels, which are important for liver function assessment.

The reagent set is supplied in various configurations including 3 x 120 mL R1 and 1 x 90 mL R2, as well as 2 x 40 mL R1 and 2 x 10 mL R2 for model 12-A7. The device is FDA 510(k) cleared with K number K941132 and is classified as Class II. It is manufactured by Pointe Scientific, Inc. and is not indicated as single-use or reusable, nor does the data specify MRI safety status or storage conditions.

Frequently asked questions

What is the Liquid AST (SGOT) Reagent Set used for?

The Liquid AST (SGOT) Reagent Set is a clinical chemistry reagent used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum, which is important for assessing liver function in clinical laboratory settings.

How is the Liquid AST (SGOT) Reagent Set supplied?

The reagent set is supplied in various configurations including 3 x 120 mL R1 and 1 x 90 mL R2, as well as 2 x 40 mL R1 and 2 x 10 mL R2 for model 12-A7.

What is the regulatory status of this device?

The Liquid AST (SGOT) Reagent Set is FDA 510(k) cleared with K number K941132, classified as Class II under product code CIT, and manufactured by Pointe Scientific, Inc.

Is the Liquid AST (SGOT) Reagent Set single-use or reusable?

The device data does not specify whether the Liquid AST (SGOT) Reagent Set is single-use or reusable, so this information should be confirmed with the manufacturer before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pointe Scientific AST (SGOT) Liquid Reagents - Fisher Sci, AST (SGOT) Reagent Set 12-A7561-100, R1: 2 x 40 mL, R2: 2 x 10 mL ..., Liquid AST (SGOT) Reagent Set - Pointe Scientific, Inc. - Yumpu

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pointe Scientific, Inc.
FDA Applicant
Pointe Scientific, Inc.,

Sources (1)

  • FDA 510(k) K941132 24 fields · synced Sep 23, 2026