ALANINE AMINOTRANSFERASE (ALT) AL100

GUDID 05055273200133

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273200133
• NIH Device Record Key: 9b523688-595a-477c-83b3-f5982fe9fcca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALANINE AMINOTRANSFERASE (ALT)
• Version Model Number: AL100
• Catalog Number: AL100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200133 [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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [ALANINE AMINOTRANSFERASE (ALT)]

• 05055273200188: AL146
• 05055273200171: AL1268
• 05055273200164: AL1205
• 05055273200157: AL1200
• 05055273200133: AL100
• 05055273200249: AL7930
• 05055273200232: AL7904
• 05055273200195: AL2360