OSOM hCG Urine 50 Test Kit 101

GUDID 00742860001017

SEKISUI DIAGNOSTICS, LLC

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00742860001017
• NIH Device Record Key: 8abfc9e2-4625-42fc-88a9-3b1aa37792db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM hCG Urine 50 Test Kit
• Version Model Number: 101
• Catalog Number: 101
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00742860001017 [Primary]
GS1	10742860001014 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974159

FDA Product Code

• JHI: Visual, pregnancy hCG, prescription use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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