AMYLASE REAGENT SET (KINETIC METHOD)

Basic Information

• Brand Name: AMYLASE REAGENT SET (KINETIC METHOD)
• Primary DI: 10673486001143
• Version / Model: A533-60
• Catalog Number: A533-60
• Company Name: TECO DIAGNOSTICS
• Labeler DUNS: 185067774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: 85c00dec-c8b6-4930-a83c-1335c05983fb

Device Description

The AMYLASE REAGENT SET (KINETIC METHOD) is used for the quantitative kinetic determination of amylase activity, using manual or automated procedures, in human serum and urine.

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
52941	Total amylase 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 quantitative measurement of total amylase in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10673486001143	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K931080	000

Storage Conditions

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