BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

• K Number: K002294
• Device Name: BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
• Manufacturer: BIOCHECK, INC.
• Date Cleared: 2000-10-02 ( 67 days)
• Product Code: CDZ
• Regulation Number: 862.1680
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.1680 Testosterone test system.

(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.