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K Number
K981373
Device Name
ALKPHASE-B ASSAY KIT
Manufacturer
METRA BIOSYSTEMS, INC.
Date Cleared
1998-05-27

(41 days)

Product Code
CIN
Regulation Number
862.1050
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Measurement of BAP is intended for use as an aid in the:

management of postmenopausal osteoporosis and Paget's disease.

monitoring of postmenopausal women on hormonal or bisphosphonate therapy

prediction of skeletal response to hormonal therapy in postmenopausal women.

Device Description

Not Found

AI/ML Overview

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§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.