Control Kit - PSA 25000003

GUDID 00816467020167

Two levels of controls for the following assays: TPSA, FPSA FPSA is not available in the US.

QUALIGEN INC.

Total prostate specific antigen (tPSA) IVD, control

• Primary Device ID: 00816467020167
• NIH Device Record Key: 9ba4d023-b6da-4d58-ad0a-6b97af576907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Kit - PSA
• Version Model Number: PSA Controls
• Catalog Number: 25000003
• 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	00816467020167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003095

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

Devices Manufactured by QUALIGEN INC.

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• 00816467020402 - FastPack® IP System: 2024-10-07
• 10816467020126 - FastPack® IP hCG Kit (30): 2023-07-06 30 Test Ported hCG Immunoassay Kit
• 10816467020034 - FastPack® Testo Kit (50): 2023-05-03 50 Test Non-Ported Testo Immunoassay Kit
• 00816467020372 - FastPack® Pro System: 2020-08-13 RoHS Compliant 7-chamber FastPack System
• 00816467020389 - FastPack SARS-CoV-2 IgG: 2020-08-13 90 Test Kit SARS-CoV-2 IgG Immunoassay
• 10816467020010 - FastPack® Total PSA Kit (50): 2020-02-06 50 Test Non-Ported TPSA Immunoassay Kit
• 20816467020017 - FastPack® IP Total PSA Kit (30): 2020-02-06 30 Test Ported TPSA Immunoassay Kit