Salicylate Assay SK511-50

GUDID 00628063401123

SEKISUI DIAGNOSTICS, LLC

Salicylate IVD, kit, enzyme spectrophotometry Salicylate IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063401123
• NIH Device Record Key: 3672afc4-654c-4f12-b3ed-027c557f97d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salicylate Assay
• Version Model Number: SK511-50
• Catalog Number: SK511-50
• 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: true
• 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	00628063401123 [Primary]

FDA Product Code

• DKJ: COLORIMETRY, SALICYLATE

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

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