QBC Diagnostics

Basic Information

• Brand Name: QBC Diagnostics
• Primary DI: 00858092006574
• Version / Model: 3406-300-000
• Catalog Number: 3406-300-000
• Company Name: DRUCKER DIAGNOSTICS
• Labeler DUNS: 022156957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: f75cf062-09c1-49d9-aa02-7c9bc93c128b

Device Description

AccuTube - Blood Collection Device (Starter Kit)

Device Characteristics

• Single Use: Yes
• 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
35770	Capillary blood collection tube IVD, no additive	A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858092006574	GS1
Unit of Use	00858092006345	GS1

Premarket Submissions

Submission Number	Supplement Number
K960827	000