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YO Home Sperm Test

Primary DI
07290016650082
Brand
YO Home Sperm Test
Company
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Model
For Galaxy 7
Published
2017-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016650082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016650082072900166500827290016650082

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514680529
Device count
1
Kit
true
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
07290016650785YO Home Sperm TestYO: Universal 3.0 packed kit for Bird & Be - 3 tes2025-01-16
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
07290016650341YO Home Sperm TestYO: Universal 2.0 packed kit - 2 testsYO-FA-01633-002020-03-31