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K Number
K011128
Device Name
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Manufacturer
NICHOLS INSTITUTE DIAGNOSTICS
Date Cleared
2001-09-06

(146 days)

Product Code
CIB,JIT,JJX
Regulation Number
862.1085
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1085 Angiotensin I and renin test system.

(a)
Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.(b)
Classification. Class II.