D3 Ultra

Basic Information

• Brand Name: D3 Ultra
• Primary DI: 30014613330431
• Version / Model: 01-013402.V2
• Catalog Number: 01-013402.V2
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-07
• Public Version: 1
• Public Version Date: 2019-03-15
• Public Version Status: New
• Public Device Record Key: 69c1b2a6-8388-4259-aabb-9f6f9bdc2a13

Device Description

Adeno DFA Reagent

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GNW	ANTISERA, CF, INFLUENZA VIRUS A, B, C	Microbiology	866.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49854	Adenovirus antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Adenovirus in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613330431	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]