BUTYRYL CHOLINESTERASE (CHE)

GUDID 05055273201093

RANDOX LABORATORIES LIMITED

Pseudocholinesterase IVD, kit, enzyme spectrophotometry

• Primary Device ID: 05055273201093
• NIH Device Record Key: 816015f9-4394-4abd-8bba-b7a6e80b6211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUTYRYL CHOLINESTERASE (CHE)
• Version Model Number: CE190
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273201093 [Primary]

FDA Product Code

• DIH: Colorimetry, Cholinesterase

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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [BUTYRYL CHOLINESTERASE (CHE)]

• 05055273201109: CE7944
• 05055273201093: CE190