THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

• K Number: K961629
• Device Name: THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
• Manufacturer: TECO DIAGNOSTICS
• Date Cleared: 1996-09-11 ( 138 days)
• Product Code: JLW
• Regulation Number: 862.1690
• 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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Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.