ARCHITECT Active-B12 (Holotranscobalamin)

• K Number: K233541
• Device Name: ARCHITECT Active-B12 (Holotranscobalamin)
• Manufacturer: Axis-Shield Diagnostics, Ltd
• Date Cleared: 2024-07-31 ( 271 days)
• Product Code: CDD
• Regulation Number: 862.1810
• 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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Summary

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Regulation Number and Section

§ 862.1810 Vitamin B

12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.