MAGLUMI 2000 FT4 130203016M

GUDID 06947145577988

Shenzhen New Industries Biomedical Engineering Co., Ltd.

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 06947145577988
• NIH Device Record Key: be828cb7-d246-4e0c-a9ee-354bb48000fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGLUMI 2000 FT4
• Version Model Number: 130203016M
• Catalog Number: 130203016M
• 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	06947145577988 [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