Dimension Vista® Flex® reagent cartridge ALTI

Basic Information

• Brand Name: Dimension Vista® Flex® reagent cartridge ALTI
• Primary DI: 00842768034312
• Version / Model: 10635565
• Catalog Number: K2143
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 3
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 8faad171-f83b-4058-b2a4-9f40565a2fa5

Device Description

Alanine Aminotransferase Flex® reagent cartridge, 480 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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	00842768034312	GS1
Unit of Use	00630414005928	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius