MagMAX™ Viral/Pathogen Proteinase K

GUDID 10190302015790

THERMO FISHER SCIENTIFIC BALTICS UAB

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 10190302015790
• NIH Device Record Key: 74e02a07-471a-450b-8b3a-18b76341d0d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MagMAX™ Viral/Pathogen Proteinase K
• Version Model Number: A42363LT
• Company DUNS: 644884074
• Company Name: THERMO FISHER SCIENTIFIC BALTICS UAB
• Device Count: 1
• DM Exempt: false
• 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	10190302015790 [Primary]

FDA Product Code

• PFT: Reagents for molecular diagnostic test systems

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by THERMO FISHER SCIENTIFIC BALTICS UAB

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• 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