LEUCINE ARYLAMIDASE (LAP)

Basic Information

• Brand Name: LEUCINE ARYLAMIDASE (LAP)
• Primary DI: 05055273204063
• Version / Model: LA561
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 2
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: b2ae1795-5f17-4e66-b056-67dec0c1fbf6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Clinical Chemistry	862.1460	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63338	Oxytocinase IVD, kit, rapid colorimetric, clinical	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273204063	GS1