NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838028793
• Version / Model: R30851501
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 8a8695a3-8d62-4003-98db-65ebbe43722b

Device Description

Cryptococcus LTX Antigen Test 50TST/KT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	866.3165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52071	Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. 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	00848838028793	GS1
Unit of Use	00848838099861	GS1

Customer Contacts

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