ALANINE AMINOTRANSFERASE (ALT)

Basic Information

• Brand Name: ALANINE AMINOTRANSFERASE (ALT)
• Primary DI: 05055273200133
• Version / Model: AL100
• Catalog Number: AL100
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 9b523688-595a-477c-83b3-f5982fe9fcca

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	862.1030	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52924	Alanine aminotransferase (ALT) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alanine aminotransferase (ALT) in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273200133	GS1

Premarket Submissions

Submission Number	Supplement Number
K923510	000