FDA.reportPublic FDA data

YO Home Sperm Test

Primary DI
07290016650785
Brand
YO Home Sperm Test
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
YO: Universal 3.0 packed kit for Bird & Be - 3 tes
Published
2025-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K241628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241628000YO Home Sperm TestMedical Electronic Systems , Ltd.2024-11-29POV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016650785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016650785072900166507857290016650785

GMDN Terms#

Term, Definition table
TermDefinition
Motile sperm concentration IVD, kit, imaging, self-testingA collection of devices intended to be used to visualize sperm and calculate motile sperm concentration in a semen specimen for the assessment of male fertility. It includes a magnifying lens and application software. The lens is intended to be attached to a compatible mobile communication device with a camera (not included) which runs the software to enable visualization and analysis of sperm in the semen specimen. It also includes materials to collect, process, and display the semen specimen. It is available [non-prescription] over-the-counter (OTC) for use in the home.

Regulatory Flags#

DUNS number
514680529
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012140792SQA-Vision Sperm Quality AnalyzerVS-MA-00892-00VS-MA-00892-002016-09-23
07290016650037SQA-V Sperm Quality AnalyzerAS-9081000AS-90810002016-09-23
07290016650822SQA-iOw Sperm Quality AnalyzerSQA-iOw Sperm Quality Analyzer2025-05-21
07290016650754YO Home Sperm TestYO 3.02025-01-16
07290016650761YO Home Sperm TestYO 3.0: Refill Pack of 3 Tests2025-01-16
07290016650778YO Home Sperm TestYO: Universal 3.0 packed kit for PROOV - 3 tests2025-01-16
07290016650792YO Home Sperm TestYO: Universal 3.0 packed kit for Quest Diagnostics2025-01-16
07290016650402SQA-iO Sperm Quality AnalyzerSQA-iO Sperm Quality Analyzer2023-09-06
07290012140136QwikCheck BeadsQwikCheck Beads 3 Levels2023-06-08
07290012140143QwikCheck Dilution KitQwikCheck Dilution Kit2023-06-08
07290012140150QwikCheck LiquefactionQwikCheck Liquefaction- 20 Vials2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitQwikCheck Beads Proficiency and Training Kit2023-06-08
07290012140891QwikCheck Vitality KitQwikCheck Vitality Kit- 5 Vials2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitQwikCheck Beads Precision and Linearity kit2023-06-08
07290016650617QwikCheck DFI KitQwikCheck DFI Kit: 10 Tests2023-06-08
07290016650587YO Home Sperm TestYO Universal 2.0 packed kit for BirdandBe - 2 testYO-FA-01912-002023-01-01
07290012140167QwikCheck Test Strips070007002016-09-29
07290016650440QwikCheck Test Strip QC KitQwikCheck Test Strip QC Kit2022-01-05
07290016650082YO Home Sperm TestFor Galaxy 72017-01-22
07290016650341YO Home Sperm TestYO: Universal 2.0 packed kit - 2 testsYO-FA-01633-002020-03-31

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
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