D3 Ultra 01-013702.V2

GUDID 30014613330479

Parainfluenza 3 DFA Reagent

DIAGNOSTIC HYBRIDS, INC.

Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 30014613330479
• NIH Device Record Key: 2aafe67f-ee08-4e05-8196-c3ea481a3683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D3 Ultra
• Version Model Number: 01-013702.V2
• Catalog Number: 01-013702.V2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613330479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092300

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 Ultra]

• 30014613330479: Parainfluenza 3 DFA Reagent
• 30014613330462: Parainfluenza 2 DFA Reagent
• 30014613330455: Parainfluenza 1 DFA Reagent
• 30014613330431: Adeno DFA Reagent
• 30014613330424: RSV DFA Reagent
• 30014613330417: Influenza B DFA Reagent
• 30014613330394: Influenza A DFA Reagent
• 30014613330387: Influenza A DFA Reagent-BULK
• 30014613330370: DFA Respiratory Virus Screening Reagent
• 30014613330363: DFA Respiratory Virus Screening Reagent - Bulk
• 30014613330356: D3 Ultra DFA Respiratory Virus ID Set
• 30014613330349: D3 Ultra DFA Parainfluenza Reagent Set
• 30014613330325: De Ultra DFA Influenza A/Influenza B Reagent Set
• 30014613330318: D3 Ultra DFA RSV Reagent Set
• 30014613330301: D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
• 30014613330295: D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
• 30014613330288: D3 Ultra DFA Respiratory Virus Screening and ID kit