NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838080913
• Version / Model: R30851502
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f9010a7f-1776-4f12-813b-e69eb5221b69

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
52732	Protease immunohaematology reagent IVD	A substance or reactant which may include bromelin, ficin, papain and/or trypsin enzymes intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838080913	GS1

Customer Contacts

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