Alkaline Phosphatase SK328-40

GUDID 00628063401192

SEKISUI DIAGNOSTICS, LLC

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