OSOM hCG Urine Ctrl Set

Basic Information

• Brand Name: OSOM hCG Urine Ctrl Set
• Primary DI: 00742860100086
• Version / Model: 134
• Catalog Number: 134
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 29c0b4f3-698e-4dba-8a83-54dd5712638d

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
JHI	Visual, pregnancy hCG, prescription use	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38265	Human chorionic gonadotropin beta-subunit (beta-HCG) 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 beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00742860100086	GS1

Premarket Submissions

Submission Number	Supplement Number
K974159	000