FastPack® IP TSH Kit (30) 25000042

GUDID 20816467020086

30 Test Ported TSH Immunoassay Kit

QUALIGEN INC.

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

• Primary Device ID: 20816467020086
• NIH Device Record Key: 9ab6e284-a393-42bd-9763-dd7d5a5f06ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastPack® IP TSH Kit (30)
• Version Model Number: TSH Immunoassay
• Catalog Number: 25000042
• Company DUNS: 959103565
• Company Name: QUALIGEN INC.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 1-877-770-6127
• Email: systemsupport@qualigeninc.com
• Phone: 1-877-770-6127
• Email: systemsupport@qualigeninc.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816467020082 [Unit of Use]
GS1	20816467020086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101390

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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