The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.


Product Overview

The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.
ISOLATOR™ 10 mL Microbial Tubes - 50C7


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: JKA

Device Name: Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1675

Third Party Flag: N

Medical Specialty: CH


Device Identifiers

Device Id: 10811877010965

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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