C-Chip

Primary DI
08809317540511
Brand
C-Chip
Company
NanoEnTek, Inc.
Model
DHC-N01
Catalog number
DHC-N01
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-N01 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3 (Fig. 1). The central square is divided into 25 small squares with triple lines and four corner squares are divided into 16 small squares.
Published
2018-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GHOHemocytometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHOHemocytometerHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540511088093175405118809317540511

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, kit, cell countA 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.

Regulatory Flags#

DUNS number
687910463
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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08809317540559FREND TSH Linearity KitFLK-TSH2018-10-01
08809317540566FREND Vitamin D Linearity KitFLK-VTD2018-10-01
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08809317540917COVID-19 total Ab Control LQFIC-COALQFIC-COALQ2020-09-02
08809317540924FREND COVID-19 total AbFREND COVID-19 total AbFRCOA 0202020-09-02
08809317540825FREND Blocking ReagentFRBR 015FRBR 0152020-03-24

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