Liquid Select Amylase Reagent 80-5451-00

GUDID 00628063400133

SEKISUI DIAGNOSTICS, LLC

Total amylase IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063400133
• NIH Device Record Key: faea32a4-077a-457f-9dd2-0eea7f1f7feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liquid Select Amylase Reagent
• Version Model Number: 80-5451-00
• Catalog Number: 80-5451-00
• 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	00628063400133 [Primary]

FDA Product Code

• JFJ: CATALYTIC METHODS, AMYLASE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Liquid Select Amylase Reagent]

• 00628063400133: 80-5451-00
• 00628063400126: 80-5383-00