FDA.reportPublic FDA data

LensHooke Semen Test Cassette

Primary DI
14719874740716
Brand
LensHooke Semen Test Cassette
Company
BONRAYBIO CO., LTD.
Model
CS0
Published
2019-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
POVSemen Analysis Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POVSemen Analysis DeviceHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180343000LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd.2018-11-16POV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719874740716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1471987474071614719874740716

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.

Regulatory Flags#

DUNS number
658872369
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
14719874742680LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2026-04-23
00859500005288FemSperm Analyzer FEMASYS INC.POV2026-02-06
00859500005318FemSperm Pack AnalysisFEMASYS INC.POV2026-02-06
00859500005349FemSperm Pack AnalysisFEMASYS INC.POV2026-02-06
14719874743502LensHooke Semen Test SlideBONRAYBIO CO., LTD.POV2026-02-06
14719874743519LensHooke Semen Test SlideBONRAYBIO CO., LTD.POV2026-02-06
14719874743526LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743533LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743564LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.POV2026-02-06
14719874743571LensHooke Sperm DNA fragmentation rapid test kit (SCD assay)BONRAYBIO CO., LTD.POV2026-02-06
20888937025846HBA®Coopersurgical, Inc.POV2025-10-20
14719874743458LensHooke Semen Analysis SystemBONRAYBIO CO., LTD.POV2025-09-01
14719874743465LensHooke Semen Analysis SystemBONRAYBIO CO., LTD.POV2025-09-01
07290016650822SQA-iOw Sperm Quality AnalyzerM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-05-21
04719874741303LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2025-02-16
14719874740747LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
14719874740808LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
14719874743069LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
14719874743076LensHooke Cleaning WipeBONRAYBIO CO., LTD.POV2025-02-16
04719874741297LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2025-02-13
07290016650754YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650761YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650778YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650785YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
07290016650792YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2025-01-16
00843277100048SwimCount Sperm Quality TestMotilitycount ApSPOV2024-06-17
07290016650402SQA-iO Sperm Quality AnalyzerM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2023-09-06
07290016650587YO Home Sperm TestM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.POV2023-01-01
00860001286533Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.POV2022-07-26
00862105000398TrakMEDTOX DIAGNOSTICS, INC.POV2022-07-05