D3

Basic Information

• Brand Name: D3
• Primary DI: 30014613338604
• Version / Model: 20-4820020
• Catalog Number: 20-4820020
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-19
• Public Version: 1
• Public Version Date: 2019-04-29
• Public Version Status: New
• Public Device Record Key: 2b63a5e5-d536-4359-9cc5-2ffdd90bf9d0

Device Description

HSV-2 Control Stock

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: Yes
• 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
OHQ	Multi-analyte controls unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52844	Herpes simplex virus 2 (HSV2) antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 2 (HSV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613338604	GS1

Customer Contacts

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