OSOM Trich V. 25 Test Kit 181

GUDID 00742860001819

SEKISUI DIAGNOSTICS, LLC

Trichomonas vaginalis antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00742860001819
• NIH Device Record Key: 2036839a-8438-4ef8-bf25-a1d629faae79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSOM Trich V. 25 Test Kit
• Version Model Number: 181
• Catalog Number: 181
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 25
• 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	00742860001819 [Primary]
GS1	10742860001816 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033864

FDA Product Code

• JWZ: KIT, SCREENING, TRICHOMONAS

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: 2016-09-16

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