OSOM hCG Urine 10 Test Kit 101-10

GUDID 00742860100154

SEKISUI DIAGNOSTICS, LLC

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

• Primary Device ID: 00742860100154
• NIH Device Record Key: c8e38d66-83b6-405d-bfbf-152a03c28c57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM hCG Urine 10 Test Kit
• Version Model Number: 101-10
• Catalog Number: 101-10
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 10
• 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: false
• 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	00742860100154 [Primary]
GS1	10742860100151 [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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