GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM

• K Number: K955770
• Device Name: GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
• Manufacturer: ABAXIS, INC.
• Date Cleared: 1996-09-09 ( 263 days)
• Product Code: JQB
• Regulation Number: 862.1360

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.

(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

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