FDA.reportPublic FDA data

LensHooke X QC Beads (For Semen)

Primary DI
04719874740733
Brand
LensHooke X QC Beads (For Semen)
Company
BONRAYBIO CO., LTD.
Model
X QC
Published
2019-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NRFMaterial, Quality Control, Semen Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRFMaterial, Quality Control, Semen AnalysisHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874740733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874740733047198747407334719874740733

GMDN Terms#

Term, Definition table
TermDefinition
Sperm concentration indicator IVD, controlA material that is used to verify the performance of an assay intended to be used to indicate the concentration of sperm in a semen specimen.

Regulatory Flags#

DUNS number
658872369
Device count
1
Premarket exempt
true
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
04719874742652LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-16
04719874742614LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742621LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742638LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
04719874742669LensHooke X QC Slide (For Semen)BONRAYBIO CO., LTD.NRF2025-02-13
00860010518106Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518113Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518120Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
00860010518137Fertility SolutionsFertility Solutions, Inc.NRF2023-10-30
08600105181066Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181134Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181202Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
08600105181370Fertility SolutionsFertility Solutions, Inc.NRF2023-09-15
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.NRF2023-06-08
00858604006016accu-beads®HAMILTON THORNE, INC.NRF2022-03-30
04719874741037LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741044LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741051LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741082LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874741099LensHooke X QC Video (For Semen)BONRAYBIO CO., LTD.NRF2020-12-24
04719874740832LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740849LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740856LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740863LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740870LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740887LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740894LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16
04719874740900LensHooke X QC Reticle (For Semen)BONRAYBIO CO., LTD.NRF2020-03-16