FDA.reportPublic FDA data

HBA®

Primary DI
20888937025846
Brand
HBA®
Company
Coopersurgical, Inc.
Model
BCT-HBA-10-US
Device description
HBA® Sperm-Hyaluronan Binding Assay
Published
2025-10-20
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
POVSemen Analysis Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POVSemen Analysis DeviceHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937025846PrimaryGS10
10888937025849Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893702584620888937025846
1088893702584910888937025849

GMDN Terms#

Term, Definition table
TermDefinition
Sperm hyaluronic acid (HA) binding IVD, kit, binding assayA collection of reagents and other associated materials intended to be used for the qualitative determination of the hyaluronic acid (HA) binding capacity of sperm in a clinical specimen, using a binding assay. This assay is also referred to as a sperm-hyaluronan binding assay and may be used as an indicator of sperm maturity during fertility assessment.

Regulatory Flags#

DUNS number
801895244
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937028508LifeGlobal® MediaH5TF-010MH5TF-010M2026-05-11
00888937028515LifeGlobal® MediaH5TF-050MH5TF-050M2026-05-11
00888937028522LifeGlobal® MediaH5TF-100MH5TF-100M2026-05-11
00888937028539LifeGlobal® MediaLGGF-050MLGGF-050M2026-05-11
00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
00888937028638LifeGlobal® MediaLGOL-100MLGOL-100M2026-05-11
00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

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
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
00862105000305Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.POV2022-06-13