ORGENTEC MICRO-ALBUMIN EIA ASSAY

• K Number: K970932
• Device Name: ORGENTEC MICRO-ALBUMIN EIA ASSAY
• Manufacturer: AMERICAN LABORATORY PRODUCTS CO., LTD.
• Date Cleared: 1997-04-08 ( 47 days)
• Product Code: JIR
• Regulation Number: 862.1645
• 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

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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.