C-Chip

Basic Information

• Brand Name: C-Chip
• Primary DI: 08809317540603
• Version / Model: DHC-M01
• Catalog Number: DHC-M01
• Company Name: NanoEnTek, Inc.
• Labeler DUNS: 687910463
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 1
• Public Version Date: 2018-11-01
• Public Version Status: New
• Public Device Record Key: 495d40e4-a81b-42ff-b74d-d18ffd00907d

Device Description

The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3. The large squares are subdivided into 20 small squares with an area of 0.0025 mm2. Cells per mL = average count per large square x dilution factor x 105 (dilution factor)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
GHO	Hemocytometer	Hematology	864.6160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55854	Full blood count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317540603	GS1