Remel

Basic Information

• Brand Name: Remel
• Primary DI: 00848838022982
• Version / Model: R21143
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 450
• Record Status: Published
• Publish Date: 2021-11-12
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 2e7fd75d-0028-455d-8a98-18a9814acd24

Device Description

BactiStaph Latex 450TST/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
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51659	Staphylococcus aureus culture isolate antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30848838022983	GS1
Primary	00848838022982	GS1

Customer Contacts

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