Acetaminophen Assay SK507-50

GUDID 00628063401185

SEKISUI DIAGNOSTICS, LLC

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• Primary Device ID: 00628063401185
• NIH Device Record Key: 8f28ba17-a7b6-4b94-a76d-a99eeee06ceb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetaminophen Assay
• Version Model Number: SK507-50
• Catalog Number: SK507-50
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Device Count: 1
• 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	00628063401185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180835

FDA Product Code

• LDP: COLORIMETRY, ACETAMINOPHEN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-10
• Device Publish Date: 2019-10-02

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• 00628063400287 - CARBON DIOXIDE L3K Assay: 2019-10-21