Dynabeads™ HLA Cell Prep™ II

GUDID 10190302006835

DYNABEADS HLA CELL PREP II

THERMO FISHER SCIENTIFIC BALTICS UAB

B lymphocyte magnetic separation reagent IVD

• Primary Device ID: 10190302006835
• NIH Device Record Key: a420dc70-a478-4842-a316-b764cd82690d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynabeads™ HLA Cell Prep™ II
• Version Model Number: 21903
• 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	10190302006835 [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: 2024-06-04
• Device Publish Date: 2018-07-03

Devices Manufactured by THERMO FISHER SCIENTIFIC BALTICS UAB

• 10190302006835 - Dynabeads™ HLA Cell Prep™ II: 2024-06-04DYNABEADS HLA CELL PREP II
• 10190302006835 - Dynabeads™ HLA Cell Prep™ II: 2024-06-04 DYNABEADS HLA CELL PREP II
• 10190302019170 - MagMAX™ Dx Viral/Pathogen NA Isolation Kit, 2000 RXN: 2024-02-13
• 10190302019187 - MagMAX™ Dx Viral/Pathogen NA Isolation Kit, 600 RXN: 2024-02-13
• 10190302018241 - MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit: 2023-03-30
• 10190302015769 - MagMAX™ MVP II BINDING BEADS: 2022-11-03
• 10190302015776 - MagMAX™ Viral/Pathogen Binding Solution: 2022-11-03
• 10190302015783 - MagMAX™ Viral/Pathogen Wash Solution: 2022-11-03
• 10190302015790 - MagMAX™ Viral/Pathogen Proteinase K: 2022-11-03