Spinalscopics Control Level 1 Set 3x3mL

Basic Information

• Brand Name: Spinalscopics Control Level 1 Set 3x3mL
• Primary DI: 00896863002080
• Version / Model: 1461-31
• Catalog Number: 1461-31
• Company Name: QUANTIMETRIX CORPORATION
• Labeler DUNS: 010717890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 1
• Public Version Date: 2018-10-29
• Public Version Status: New
• Public Device Record Key: e9d069da-2833-49a2-a546-34430fab9e15

Device Description

Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth.

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
JPK	Mixture, Hematology Quality Control	Hematology	864.8625	2
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

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	00896863002080	GS1
Secondary	M05114613110	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970862	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius