FastPack® IP SHBG 25000081

GUDID 20816467020345

30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls

QUALIGEN INC.

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 20816467020345
• NIH Device Record Key: cf2e7782-8108-48fa-9c05-461197bd4732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastPack® IP SHBG
• Version Model Number: FastPack® IP SHBG 30 Immunoassay
• Catalog Number: 25000081
• 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	00816467020341 [Unit of Use]
GS1	20816467020345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182521

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2019-03-25
• Device Publish Date: 2019-03-15

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