AST AS2359

GUDID 05055273200454

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.

RANDOX LABORATORIES LIMITED

Aspartate aminotransferase (AST) isoenzyme IVD, reagent

• Primary Device ID: 05055273200454
• NIH Device Record Key: 8cdd8ad6-7794-4899-9eff-90148e2ebf4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AST
• Version Model Number: AS2359
• Catalog Number: AS2359
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Stable for 14 days at +2 to +8°C or 24 hours at +15 to +25°C once reconstituted.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923505

FDA Product Code

• CIT: Nadh Oxidation/Nad Reduction, Ast/Sgot

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [AST]

• 05055273208245: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200508: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200492: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200485: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200478: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200461: The AST method used on the Dimension® clinical chemistry system is an in vitro diagnostic test
• 05055273200454: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200430: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200423: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr
• 05055273200416: The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotr