Light Diagnostics™ HSV 1&2 Typing DFA Kit

Basic Information

• Brand Name: Light Diagnostics™ HSV 1&2 Typing DFA Kit
• Primary DI: 04053252620638
• Version / Model: 3291
• Catalog Number: 3291
• Company Name: EMD Millipore Corporation
• Labeler DUNS: 829517072
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 7a54a66b-a082-4553-9d37-dad88d25fa5f
• Distribution End Date: 2023-04-30

Device Description

HSV 1 & 2 Typing DFA Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
GQL	Antisera, Fluorescent, Herpesvirus Hominis 1,2	Microbiology	866.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49537	Herpes simplex virus 1 & 2 (HSV1 & 2) 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) 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	04053252620638	GS1

Premarket Submissions

Submission Number	Supplement Number
K081527	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius