FDA.reportPublic FDA data

Fertility Solutions

Primary DI
86001051819986
Brand
Fertility Solutions
Company
Fertility Solutions, Inc.
Model
SA400
Catalog number
SA400
Device description
Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GHOHemocytometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHOHemocytometerHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010518199PrimaryGS10
08600105181998PrimaryGS10
86001051819986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010518199008600105181998600105181990860010518199
08600105181998086001051819988600105181998
8600105181998686001051819986

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20Micrometer

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
794781583
Device count
25
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08600105181066Fertility SolutionsFSI103FSI1032023-09-15
08600105181134Fertility SolutionsFSI203FSI2032023-09-15
08600105181202Fertility SolutionsFSI111FSI1112023-09-15
08600105181370Fertility SolutionsFSI211FSI2112023-09-15
08600105181752AQCAQC109AQC1092023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14719874742338LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874742529LensHooke Prestained Morphology SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874743045LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742335LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742526LensHooke Prestained Morphology Slide BONRAYBIO CO., LTD.GHO2025-02-16
24719874743035LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
00860010518199Fertility SolutionsFertility Solutions, Inc.GHO2023-10-30
08600105181998Fertility SolutionsFertility Solutions, Inc.GHO2023-09-15
00664816000212LW Scientific, Inc.LW SCIENTIFIC, INC.GHO2022-09-12
08809317540665C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540672C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540689C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540696C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540702C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540719C-ChipNanoEnTek, Inc.GHO2019-06-25
00664816001769LW Scientific LW SCIENTIFIC, INC.GHO2019-01-23
08809317540511C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540573C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540580C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540603C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540597C-ChipNanoEnTek, Inc.GHO2018-10-01
10805360018026MicroCellVITROLIFE INC.GHO2018-04-23
10805360018033MicroCellVITROLIFE INC.GHO2018-04-23
04061609000354Cover Slips (for Hemacytometer)BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000378Hemocytometer (CE) Fuchs-RosenthalBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000385Hemocytometer (CE) Fuchs-Rosenthal brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000392Hemocytometer (CE) Neubauer improvedBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000408Hemocytometer (CE) Neubauer improved brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000422Hemocytometer Neubauer improved, disposable, made of glass.BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06