CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227
• Primary DI: 00817302020298
• Version / Model: AU-227
• Catalog Number: AU-227
• 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: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 2b1e433a-f2b2-418d-8a45-eda2119dfdf3

Device Description

AMY (Amylase) 3 x 100 tests

Device Characteristics

• Single Use: No
• 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
JFJ	CATALYTIC METHODS, AMYLASE	Clinical Chemistry	862.1070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59073	Amylase isoenzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an amylase isoenzyme in a clinical specimen, using a spectrophotometry method. This test is typically used to detect salivary or pancreatic alpha-amylase to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302020298	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Kit contains 3 R1 bottles and 1 package insert
Total Volume	20	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable when stored at 2-8° C until expiration date