Duns Number:687910463
Device Description: The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) co 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)
Catalog Number
DHC-M01
Brand Name
C-Chip
Version/Model Number
DHC-M01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GHO
Product Code Name
Hemocytometer
Public Device Record Key
495d40e4-a81b-42ff-b74d-d18ffd00907d
Public Version Date
November 01, 2018
Public Version Number
1
DI Record Publish Date
October 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |