Method Verification Kit - PSA 25000017

GUDID 00816467020075

QUALIGEN INC.

Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control Total prostate specific antigen (tPSA) IVD, control

• Primary Device ID: 00816467020075
• NIH Device Record Key: c8b8bd96-7b4c-4649-a172-e8262559a6c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Method Verification Kit - PSA
• Version Model Number: TPSA Verifier
• Catalog Number: 25000017
• Company DUNS: 959103565
• Company Name: QUALIGEN INC.
• 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: 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
• Phone: 1-877-770-6127
• Email: systemsupport@qualigeninc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816467020075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062957

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-16

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• 30816467020014 - FastPack® IP Total PSA Kit (90): 2020-02-06 90 Test Ported TPSA Immunoassay Kit
• 00816467020020 - Calibrator Kit - PSA: 2020-02-06