FDA.reportPublic FDA data

AQC

Primary DI
08600105181752
Brand
AQC
Company
Fertility Solutions, Inc.
Model
AQC109
Catalog number
AQC109
Device description
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-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
DGQWhole Blood Plasma, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DGQWhole Blood Plasma, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600105181752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600105181752086001051817528600105181752

GMDN Terms#

Term, Definition table
TermDefinition
Sperm antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 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
08600105181066Fertility SolutionsFSI103FSI1032023-09-15
08600105181134Fertility SolutionsFSI203FSI2032023-09-15
08600105181202Fertility SolutionsFSI111FSI1112023-09-15
08600105181370Fertility SolutionsFSI211FSI2112023-09-15
86001051819986Fertility SolutionsSA400SA4002023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010518175AQCFertility Solutions, Inc.DGQ2023-10-30
00816784020925ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mLLgc Clinical Diagnostics, Inc.DGQ2021-08-18
00816784020932ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mLLgc Clinical Diagnostics, Inc.DGQ2021-08-18
00816784020130ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020147ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020154ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020161ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020178ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020185ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020192ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020208ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020239ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020246ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020277ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020284ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020345ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020352ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020369ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020406ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020420ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020482ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020499ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020635ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020642ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020659ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020666ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020673ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020680ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020697ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24
00816784020703ACCURUN®Lgc Clinical Diagnostics, Inc.DGQ2018-09-24