QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives, Microscope, and Centrifuge (230V)


Product Overview

QBC F.A.S.T. AFB Detection System
QBC Diagnostics - 427414


Device Description

A collection of chemical agents, dyes and/or solutions intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen for subsequent visualization, examination, identification and/or differentiation.


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: GKZ

Device Name: Counter, Differential Cell

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

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: 864.5220

Third Party Flag: N

Medical Specialty: HE


Code: JSY

Device Name: Kit, Identification, Mycobacteria

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

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: 866.2660

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 00858092006208

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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