CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT AU-241

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® AST RGT. KIT AU-241
• Primary DI: 00817302020335
• Version / Model: AU-241
• Catalog Number: AU-241
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 46fec88a-a8de-42d8-a96b-61aba0757c62

Device Description

AST (Aspartate Aminotransferase) 3 x 250 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
CIT	Nadh oxidation/nad reduction, ast/sgot	Clinical Chemistry	862.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52953	Aspartate aminotransferase (AST) isoenzyme IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302020335	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Kit contains 3 R1, 3 R2 & 1 package insert
Total Volume	44	Milliliter
Total Volume	8	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable when stored at 2-8° C until expiration date
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C