The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.


Product Overview

The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.
ISOLATOR™ 1.5 mL Microbial Tubes - 50C5


Device Description

A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.


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: LIO

Device Name: Device, Specimen Collection

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.2900

Third Party Flag: Y

Medical Specialty: MI


Device Identifiers

Device Id: 10811877010958

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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