Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit

Basic Information

• Brand Name: Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit
• Primary DI: 00816068020856
• Version / Model: 111280
• Catalog Number: 111280
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-21
• Public Version: 1
• Public Version Date: 2020-07-29
• Public Version Status: New
• Public Device Record Key: 7c458f37-6697-4fac-811d-2e1550efde53

Device Description

Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells.

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: 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
JPK	Mixture, Hematology Quality Control	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56225	White blood cell 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 white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	No	Active
55868	Red blood cell 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 red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816068020856	GS1

Customer Contacts

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