AMY (Amylase) 3 x 100 tests

AMY (Amylase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227 - AU-227

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).

• Kit contains 3 R1 bottles and 1 package insert
• Total Volume: 20 Milliliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JFJ

Device Name: Catalytic Methods, Amylase

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1070

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00817302020298

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A