D3 Fastpoint 01-120001.B1

GUDID 30014613330790

FASTPOINT FLUA/B KIT BX 1

DIAGNOSTIC HYBRIDS, INC.

Influenza A/B virus antigen IVD, kit, fluorescent immunoassay Influenza A/B virus antigen IVD, kit, fluorescent immunoassay Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex Multiple-genus respiratory virus antigen IVD, kit, multiplex

• Primary Device ID: 30014613330790
• NIH Device Record Key: e903291d-de00-4e4a-b942-38ddf76dfacd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D3 Fastpoint
• Version Model Number: 01-120001.B1
• Catalog Number: 01-120001.B1
• 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	30014613330790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092882

FDA Product Code

• GNW: ANTISERA, CF, INFLUENZA VIRUS A, B, C

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: 2019-03-15
• Device Publish Date: 2019-03-07

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