OSOM Trich.10T Cntrl Kit

Basic Information

• Brand Name: OSOM Trich.10T Cntrl Kit
• Primary DI: 00742860100130
• Version / Model: 182
• Catalog Number: 182
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 31678ae9-3f7a-49dd-92b3-6a3701ae197e

Device Characteristics

• Single Use: No
• 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
JWZ	KIT, SCREENING, TRICHOMONAS	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52473	Trichomonas vaginalis antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from the parasitic protozoan Trichomonas vaginalis in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00742860100130	GS1
Unit of Use	10742860100137	GS1

Premarket Submissions

Submission Number	Supplement Number
K033864	000