FastPack® IP System 08000043, 08000043-R, 08000043-X

GUDID 00816467020006

QUALIGEN INC.

Chemiluminescent immunoassay analyser IVD, automated

• Primary Device ID: 00816467020006
• NIH Device Record Key: 251b681b-2143-49d5-8cd2-00943302e1b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastPack® IP System
• Version Model Number: IP System
• Catalog Number: 08000043, 08000043-R, 08000043-X
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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
• 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
• 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
• 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
• Phone: 1-877-770-6127
• Email: systemsupport@qualigeninc.com
• Phone: 1-877-770-6127
• Email: systemsupport@qualigeninc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816467020006 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [FastPack® IP System]

• 00816467020334: RoHS Compliant FastPack System
• 00816467020006: IP System
• 00816467020402: IP System
• 00816467020396: IP System