Alkaline Phosphatase SK328-40

GUDID 00628063401192

SEKISUI DIAGNOSTICS, LLC

Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063401192
• NIH Device Record Key: 8762c82d-d573-45c4-b0a1-b23bbe2f4d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alkaline Phosphatase
• Version Model Number: SK328-40
• Catalog Number: SK328-40
• 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	00628063401192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003093

FDA Product Code

• CJE: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

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: 2018-12-31
• Device Publish Date: 2018-11-28

On-Brand Devices [Alkaline Phosphatase]

• 00628063401192: SK328-40
• 00628063400096: SK328-20