FDA.reportPublic FDA data

Hemocytometer (CE) Fuchs-Rosenthal

Primary DI
04061609000378
Brand
Hemocytometer (CE) Fuchs-Rosenthal
Company
BIOANALYTIC GmbH, biomed. Analysentechnik
Model
CC.FURO
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04061609000378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061609000378040616090003784061609000378

GMDN Terms#

Term, Definition table
TermDefinition
Microscope counting chamber IVDA counting chamber intended to be used for the microscopic enumeration of cells, cellular particles, or other biological components present in clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
327536728
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061609000699Thrombo-TIC 1:100 pur004015-6011DMD2019-02-01
04061609000712Thrombo-TIC 1:25 pur004015-6012DMD2019-02-01
04061609000736Thrombo-TIC 1:25 pur 004015-6013DMD2019-02-01
04061609000019Sperm-TIC 1:20003604-60052018-02-13
04061609000026Sperm-TIC 1:20 plus003604-61002018-02-13
04061609000033Ejaculate-TIC 1:20003605-60052018-02-13
04061609000040Ejaculate-TIC 1:20 plus003605-61002018-02-13
04061609000057Leuko-TIC VT004005-60102018-02-06
04061609000064Leuko-TIC VT plus004005-61002018-02-06
04061609000071Leuko-TIC SF 1:100004008-60102018-02-06
04061609000088Leuko-TIC SF 1:100 plus004008-61002018-02-06
04061609000095Ery-TIC 1:200004012-00062018-02-06
04061609000101Ery-TIC 1:200 plus004012-00072018-02-06
04061609000118EryCount pur004012-01002018-02-06
04061609000125EryCount pur004012-05002018-02-06
04061609000132Ery-TIC 1:200004012-60102018-02-06
04061609000149Leuko-TIC 1:20 blau004013-00062018-02-06
04061609000156Leuko-TIC 1:20 blau plus004013-00072018-02-06
04061609000163LeukoCount blau004013-01002018-02-06
04061609000170LeukoCount blau004013-05002018-02-06

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
08809317540597C-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
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