FDA.reportPublic FDA data

N/A

Primary DI
60888937900028
Brand
N/A
Company
ORIGIO INC.
Model
07-SAK-10
Device description
SEMEN ANALYSIS KIT
Published
2016-08-22
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915229000SEMEN ANALYSIS KITHumagen Fertility Diagnostics, Inc.1994-08-30POV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937900028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088893790002860888937900028

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787068394
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937907834N/AMXL3-PLG-PGD2016-08-22
00888937907872STRIPPERMXL3-STR2016-08-22
00888937907889N/AMXL3-STR-BP-DE2016-08-22
00888937907902N/AMXL3-STR-BP-SW2016-08-22
00888937907919STRIPPERMXL3-STR-CC2016-08-22
00888937907926STRIPPERMXL3-STR-CGR2016-08-22
00888937907933STRIPPERMXL3-STR-PGD2016-08-22
00888937907940STRIPPERMXL3-STR-PGD-CG2016-08-22
20888937906220STRIPPER MXL3-1002016-08-22
20888937906237STRIPPER MXL3-1252016-08-22
20888937906244STRIPPER MXL3-1352016-08-22
20888937906251STRIPPER MXL3-1502016-08-22
20888937906268STRIPPER MXL3-1752016-08-22
20888937906275STRIPPER MXL3-2002016-08-22
20888937906282STRIPPER MXL3-502016-08-22
20888937906299STRIPPER MXL3-6002016-08-22
20888937906305STRIPPER MXL3-752016-08-22
20888937906312STRIPPERMXL3-CC2016-08-22
20888937906329STRIPPERMXL3-IND-1002016-08-22
20888937906336STRIPPERMXL3-IND-1252016-08-22

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