ISE Reference Reagent

GUDID 00811403011629

Diamond Diagnostics Inc.

Ion selective electrode (ISE) reference solution IVD, reagent

• Primary Device ID: 00811403011629
• NIH Device Record Key: 6dca314b-8319-4713-b9ba-3291b8476e49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Reference Reagent
• Version Model Number: BK-467935D
• Company DUNS: 947514303
• Company Name: Diamond Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00811403011629 [Primary]

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: 2023-06-19
• Device Publish Date: 2023-06-10

On-Brand Devices [ISE Reference Reagent]

• 00811403011629: BK-467935D
• 00811403011964: BK-A17657D