MAGLUMI 2000 TSH 130603013M

GUDID 06947145500023

Shenzhen New Industries Biomedical Engineering Co., Ltd.

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 06947145500023
• NIH Device Record Key: 47d84b52-a29f-4721-a066-ed3e55cee5d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGLUMI 2000 TSH
• Version Model Number: 130603013M
• Catalog Number: 130603013M
• 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	06947145500023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162698

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

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 TSH]

• 06947145500023: 130603013M
• 06947145500016: 130203013M