IMMULITE TOTAL TESTOSTERONE

• K Number: K955870
• Device Name: IMMULITE TOTAL TESTOSTERONE
• Manufacturer: DIAGNOSTIC PRODUCTS CORP.
• Date Cleared: 1996-02-06 ( 40 days)
• Product Code: CDZ
• Regulation Number: 862.1680
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K032881

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

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.