FDA.reportPublic FDA data

AQC

Primary DI
00860010518151
Brand
AQC
Company
Fertility Solutions, Inc.
Model
AQC205
Catalog number
AQC205
Device description
Sperm Morphology Quality Control - Unstained. 2 unstained, fixed, glass sperm morphology smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010518151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010518151008600105181518600105181510860010518151

GMDN Terms#

Term, Definition table
TermDefinition
Sperm morphology/viability control IVDA prepared slide with a fixed semen smear, or a high-resolution colour printed image of stained or unstained normal sperm, intended to be used as reference material in the analysis of a semen specimen, to determine sperm morphology and/or viability. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark, dry place at 20-25 C

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010518144AQCAQC105AQC1052024-04-15
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
86001051819986Fertility SolutionsSA400SA4002023-09-15

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