Dynabeads™ HLA Cell Prep™ II

Dynabeads™ HLA Cell Prep™ II - 21903

Device Description

A substance or reactant intended to be used on clinical specimens for the isolation of B-lymphocytes from a white cell preparation using magnetic beads to achieve component separation.

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: JCF

Device Name: Lymphocyte Separation Medium

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 864.8500

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 10190302006835

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