MAGLUMI 2000 FT4 130603016M

GUDID 06947145577971

Shenzhen New Industries Biomedical Engineering Co., Ltd.

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 06947145577971
• NIH Device Record Key: 1a7a7a9e-06c3-4280-b07b-4715e6147d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGLUMI 2000 FT4
• Version Model Number: 130603016M
• Catalog Number: 130603016M
• Company DUNS: 421745241
• Company Name: Shenzhen New Industries Biomedical Engineering Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947145577971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182423

FDA Product Code

• CEC: Radioimmunoassay, Free Thyroxine

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: 2022-08-10
• Device Publish Date: 2022-08-02

On-Brand Devices [MAGLUMI 2000 FT4]

• 06947145577988: 130203016M
• 06947145577971: 130603016M