QBC Diagnostics

Basic Information

• Brand Name: QBC Diagnostics
• Primary DI: 00858092006109
• Version / Model: 427761
• Catalog Number: 427761
• Company Name: DRUCKER DIAGNOSTICS
• Labeler DUNS: 022156957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 30278979-8fb8-4e2d-a748-5194131ee121

Device Description

QBC F.A.S.T. Malaria Stain 250 mL Bottle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52322	Multiple Plasmodium species nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858092006109	GS1

Premarket Submissions

Submission Number	Supplement Number
K891276	000