NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838091834
• Version / Model: 7116-70
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-09
• Public Version: 4
• Public Version Date: 2021-11-15
• Public Version Status: Update
• Public Device Record Key: d2982896-85ce-4b54-85fd-57745063a235

Device Description

MYCO PZA KIT

Device Characteristics

• Single Use: Yes
• 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
MJA	Susceptibility Test Powders, Antimycobacterial	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62407	Anti-tuberculosis (anti-TB) drug susceptibility testing reagent kit IVD	A collection of reagents and other associated materials intended to be added to a culture medium containing a culture isolate of Mycobacteruim tuberculosis from a clinical specimen, to determine antimicrobial susceptibility to an anti-tuberculosis drug [e.g., pyrazinamide (PZA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838091834	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052323	000