FDA.reportPublic FDA data

Fertility Solutions

Primary DI
08600105181066
Brand
Fertility Solutions
Company
Fertility Solutions, Inc.
Model
FSI103
Catalog number
FSI103
Device description
Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - high and low concentrations. https://www.fertilitysolutions.com/product-category/sperm-count-quality-control
Published
2023-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
08600105181066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600105181066086001051810668600105181066

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-491-0030businessmgr@fertilitysolutions.com

Regulatory Flags#

DUNS number
794781583
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010518144AQCAQC105AQC1052024-04-15
00860010518151AQCAQC205AQC2052024-04-15
00860010518168AQCAQC107AQC1072024-04-15
00860010518182AQCAQC305AQC3052024-04-15
00860010518199Fertility SolutionsSA400SA4002023-10-30
00860010518106Fertility SolutionsFSI103FSI1032023-10-30
00860010518113Fertility SolutionsFSI203FSI2032023-10-30
00860010518120Fertility SolutionsFSI111FSI1112023-10-30
00860010518137Fertility SolutionsFSI211FSI2112023-10-30
00860010518175AQCAQC109AQC1092023-10-30
08600105181998Fertility SolutionsSA400SA4002023-09-15
08600105181134Fertility SolutionsFSI203FSI2032023-09-15
08600105181202Fertility SolutionsFSI111FSI1112023-09-15
08600105181370Fertility SolutionsFSI211FSI2112023-09-15
08600105181752AQCAQC109AQC1092023-09-15
86001051819986Fertility SolutionsSA400SA4002023-09-15

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
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
04719874740733LensHooke X QC Beads (For Semen)BONRAYBIO CO., LTD.NRF2019-10-07