D3 Fastpoint

Basic Information

• Brand Name: D3 Fastpoint
• Primary DI: 30014613330820
• Version / Model: 01-120002.B1
• Catalog Number: 01-120002.B1
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-22
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 9ca47713-31a9-435e-b54b-7297892a0834

Device Description

FASTPOINT RSV/MPV KIT BX 1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
LKT	RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA	Microbiology	866.3480	1
OMG	Antisera, fluorescent, human metapneumovirus	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48245	Multiple-genus respiratory virus antigen IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613330820	GS1

Customer Contacts

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