Dynabeads™ HLA Cell Prep™ II

GUDID 10190302006842

DYNABEADS HLA CELL PREP II

THERMO FISHER SCIENTIFIC BALTICS UAB

B lymphocyte magnetic separation reagent IVD

• Primary Device ID: 10190302006842
• NIH Device Record Key: 9362036d-c267-46f8-9052-609f5cc7d305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynabeads™ HLA Cell Prep™ II
• Version Model Number: 21904
• Company DUNS: 644884074
• Company Name: THERMO FISHER SCIENTIFIC BALTICS UAB
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190302006842 [Primary]

FDA Product Code

• JCF: LYMPHOCYTE SEPARATION MEDIUM

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-03-14
• Device Publish Date: 2018-07-03

On-Brand Devices [Dynabeads™ HLA Cell Prep™ II]

• 10190302006835: DYNABEADS HLA CELL PREP II
• 10190302006842: DYNABEADS HLA CELL PREP II