ALT AL3801

GUDID 05055273200218

An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma.

RANDOX LABORATORIES LIMITED

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 05055273200218
• NIH Device Record Key: 3eed3f56-bd77-44b3-b5e3-32fad4754da4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALT
• Version Model Number: AL3801
• Catalog Number: AL3801
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923510

FDA Product Code

• CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt

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: 2019-01-21
• Device Publish Date: 2018-12-21

On-Brand Devices [ALT]

• 05055273200225: An ALT test system is a device intended for the quantitative in vitro determination of of Alanin
• 05055273200218: An ALT test system is a device intended for the quantitative in vitro determination of Alanine A