VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)

• K Number: K964720
• Device Name: VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
• Manufacturer: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
• Date Cleared: 1997-02-04 ( 71 days)
• Product Code: CGJ
• Regulation Number: 862.1300
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: 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

§ 862.1300 Follicle-stimulating hormone test system.

(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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.