N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

• K Number: K003609
• Device Name: N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
• Manufacturer: OSTEOMETER BIOTECH A/S
• Date Cleared: 2001-05-16 ( 175 days)
• Product Code: NEO
• Regulation Number: 862.1050
• 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

§ 862.1050 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.