Product Overview

IMMAGE 800
IMMAGE - A15445


Device Description

An electrically-powered manual laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of light absorption and/or light scatter caused by particles (e.g., bacteria) and/or other biological components suspended in a clinical specimen using a photometric detection system. It is generally used to measure the concentration of a target analyte in solution.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: JQX

Device Name: Nephelometer, For Clinical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2700

Third Party Flag: N

Medical Specialty: CH


Device Identifiers

Device Id: 15099590265403

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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