ASTUTE140 Meter Kit

ASTUTE140 Meter Kit - 500017

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PIG

Device Name: Acute Kidney Injury Test System

Device Class: 2

Physical State: The test system may include clinical analyzers, reagents, calibrators, and controls.

Definition: An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Assay to measure analyte(s) that are markers of Acute Kidney Injury

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The test system is an in vitro diagnostic device that measures human samples.

Regulation Number: 862.1220

Third Party Flag: N

Medical Specialty: CH

Device Id: B0745000170

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A