VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

• K Number: K964558
• Device Name: VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
• Manufacturer: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
• Date Cleared: 1996-12-16 ( 33 days)
• Product Code: JLW
• Regulation Number: 862.1690
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K081543

Intended Use

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Device Description

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Summary

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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.