LEUCINE ARYLAMIDASE (LAP)

LEUCINE ARYLAMIDASE (LAP) - LA561

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of oxytocinase (also known as cysteine aminopeptidase or leucine arylamidase) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the diagnosis of jaundice, liver cirrhosis, carcinoma, or to indicate pregnancy. It is not intended to be used for self-testing.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JGG

Device Name: L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 862.1460

Third Party Flag: N

Medical Specialty: CH

Device Id: 05055273204063

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