FDA.reportPublic FDA data

C-Chip

Primary DI
08809317540597
Brand
C-Chip
Company
NanoEnTek, Inc.
Model
DHC-F01
Catalog number
DHC-F01
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-F01 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm.
Published
2018-10-01
Public version status
Update
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
08809317540597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540597088093175405978809317540597

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809317540252ADAM-rWBCADAM-rWBC ADAM-rWBC2018-06-11
08809317540269ADAM-rWBC KitAD1K-050AD1K-0502016-09-30
08809317540276ADAM-rWBC SystemADAM-rWBC SystemADAM-rWBC System2016-09-30
08809317540498ADAM-rWBC2ADAM-rWBC2ADAM-rWBC22018-06-19
08809317540504ADAM-rWBC2 SystemADAM-rWBC2 SystemADAM-rWBC2 System2018-06-19
08809317540207FREND SystemF102018-05-04
08809317540153FREND TestosteroneFRTE-HBFRTE 0202016-11-28
08809317540375FREND TestosteroneFRTE-APFRTEAP 0202018-05-04
08809317540467FREND APF10AP2018-06-11
08809317541143r-Control RBC and PLTADRCADRC 0202021-12-08
08809317540993ADAM-rWBC HTADAM-rWBC HTADAM-rWBC HT2021-02-15
08809317541006ADAM-rWBC KitADHK-050ADHK-0502021-02-15
08809317540528FREND Free T4 Linearity KitFLK-FT42018-10-01
08809317540559FREND TSH Linearity KitFLK-TSH2018-10-01
08809317540566FREND Vitamin D Linearity KitFLK-VTD2018-10-01
08809317540627ADAMIIADAMII2020-09-02
08809317540634ADAMII-CD34 KitCD34K-050CD34K-0502020-09-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14719874742338LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874742529LensHooke Prestained Morphology SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874743045LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742335LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742526LensHooke Prestained Morphology Slide BONRAYBIO CO., LTD.GHO2025-02-16
24719874743035LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
00860010518199Fertility SolutionsFertility Solutions, Inc.GHO2023-10-30
08600105181998Fertility SolutionsFertility Solutions, Inc.GHO2023-09-15
86001051819986Fertility SolutionsFertility Solutions, Inc.GHO2023-09-15
00664816000212LW Scientific, Inc.LW SCIENTIFIC, INC.GHO2022-09-12
08809317540665C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540672C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540689C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540696C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540702C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540719C-ChipNanoEnTek, Inc.GHO2019-06-25
00664816001769LW Scientific LW SCIENTIFIC, INC.GHO2019-01-23
08809317540511C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540573C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540580C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540603C-ChipNanoEnTek, Inc.GHO2018-10-01
10805360018026MicroCellVITROLIFE INC.GHO2018-04-23
10805360018033MicroCellVITROLIFE INC.GHO2018-04-23
04061609000354Cover Slips (for Hemacytometer)BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000378Hemocytometer (CE) Fuchs-RosenthalBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000385Hemocytometer (CE) Fuchs-Rosenthal brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000392Hemocytometer (CE) Neubauer improvedBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000408Hemocytometer (CE) Neubauer improved brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000422Hemocytometer Neubauer improved, disposable, made of glass.BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06