FDA.reportPublic FDA data

LensHooke Prestained Morphology Slide

Primary DI
14719874742529
Brand
LensHooke Prestained Morphology Slide
Company
BONRAYBIO CO., LTD.
Model
CR0 Package-50pcs-US-HT
Catalog number
CR0
Published
2025-02-16
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
14719874742529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1471987474252914719874742529

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658872369
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
14719874742680LensHooke Semen Quality AnalyzerX3 PRO SEX3 PRO SE2026-04-23
14719874743502LensHooke Semen Test SlideCS3-01 Package-25pcs-US-HTCS3-01 10um2026-02-06
14719874743519LensHooke Semen Test SlideCS3-01 Package-25pcs-US-BRCS3-01 10um2026-02-06
14719874743526LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay)R11 Plus-01 Package-10 tests-US-BRR11 Plus-012026-02-06
14719874743533LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)R11 Plus-01 Package-10 tests-US-HTR11 Plus-012026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-BRR10 Plus-012026-02-06
14719874743571LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus-01 Package-10 tests-US-HTR10 Plus-012026-02-06
14719874742796LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-BRR10 Plus2025-02-16
14719874742802LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)R10 Plus Package-10 tests-US-HTR10 Plus2025-02-16
14719874743458LensHooke Semen Analysis SystemX12 Package-1pcs-US HT(Plug UL)/RXX12 PRO2025-09-01
14719874743465LensHooke Semen Analysis SystemX12 Package-1pcs-US BR(Plug UL)/RXX12 PRO2025-09-01
24719874742267LensHooke Sperm Separation DeviceCA0 Package-150 sets-EN-CECA02025-04-10
14719874742222LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-HTCA12025-02-16
14719874742239LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-HTCA02025-02-16
14719874742253LensHooke Sperm Separation DeviceCA0 Package-25 sets-US-BRCA02025-02-16
14719874742284LensHooke Sperm Separation DeviceCA1 Package-25 sets-US-BRCA12025-02-16
24719874742250LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-BRCA02025-02-16
24719874742236LensHooke Sperm Separation DeviceCA0 Package-150 sets-US-HTCA02025-02-16
04719874741242LensHooke Liquefaction EnzymeCK1 Package-10pcs-US HTCK12025-02-16
04719874741303LensHooke Semen Quality AnalyzerUL-US-X1.E206X1 PRO2025-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14719874742338LensHooke Semen Test 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
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