Quebec® Digital Darkfield Colony Counter

Basic Information

• Brand Name: Quebec® Digital Darkfield Colony Counter
• Primary DI: 00812559011440
• Version / Model: 13332700
• Company Name: REICHERT, INC.
• Labeler DUNS: 126650253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-12
• Public Version: 1
• Public Version Date: 2025-08-20
• Public Version Status: New
• Public Device Record Key: ec9326dd-6ab6-4011-b819-13b32baa3e42

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZB	Automated Colony Counter	Microbiology	866.2170	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15126	Colony counter IVD, manual	A device designed to provide a lighted surface upon which bacteria colonies can be manually counted with a high degree of accuracy. The surface divides an agar plate into grids so that the operator can manually count the colonies in each grid and keep track of which units have already been counted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812559011440	GS1