R & D Systems, Inc. CBC-PIX Hematology Control

Basic Information

• Brand Name: R & D Systems, Inc. CBC-PIX Hematology Control
• Primary DI: 00815762021978
• Version / Model: P002
• Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
• Labeler DUNS: 087248183
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-05
• Public Version: 2
• Public Version Date: 2025-12-02
• Public Version Status: Update
• Public Device Record Key: 22c5ca3f-6a22-4864-b003-2193de22f151
• Distribution End Date: 2025-12-01

Device Description

CBC-PIX Hematology Control

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55866	Full blood count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815762021978	GS1

Customer Contacts

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