D3 Fastpoint 01-120002

GUDID 30014613330813

D3 FASTPOINT RSV/MPV KIT

DIAGNOSTIC HYBRIDS, INC.

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• Primary Device ID: 30014613330813
• NIH Device Record Key: 10fd7c04-9be6-4660-934e-c981f709bbab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D3 Fastpoint
• Version Model Number: RSV/MPV ID Kit
• Catalog Number: 01-120002
• Company DUNS: 117359612
• Company Name: DIAGNOSTIC HYBRIDS, 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(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613330813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093233

FDA Product Code

• OMG: Antisera, fluorescent, human metapneumovirus

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: 2016-09-15

On-Brand Devices [D3 Fastpoint]

• 30014613330875: L-DFA Parainfluenza Virus/Adenovirus Reagent
• 30014613330868: L-DFA RSV/MPV Reagent
• 30014613330851: L-DFA Influenza A/Influenza B Reagent
• 30014613330844: Re-Suspension Buffer
• 30014613330837: FASTPOINT RSV/MPV KIT BX 2
• 30014613330820: FASTPOINT RSV/MPV KIT BX 1
• 30014613330813: D3 FASTPOINT RSV/MPV KIT
• 30014613330806: FASTPOINT FLUA/B KIT BX 2
• 30014613330790: FASTPOINT FLUA/B KIT BX 1
• 30014613330783: FASTPOINT FLUA/B KIT
• 30014613330776: D3 FASTPOINT LDFA VIR IDKIT BX
• 30014613330769: D3 FASTPOINT LDFA VIR IDKIT BX
• 30014613330752: D3 FASTPOINT RESP VIRUS ID KIT
• 30014613338727: L-DFA RSV/MPV Antigen Control Slides
• 30014613338710: L-DFA Influenza A/Influenza B Antigen Control Slides