AQC

Basic Information

• Brand Name: AQC
• Primary DI: 00860010518175
• Version / Model: AQC109
• Catalog Number: AQC109
• Company Name: Fertility Solutions, Inc.
• Labeler DUNS: 794781583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-30
• Public Version: 1
• Public Version Date: 2023-11-07
• Public Version Status: New
• Public Device Record Key: 725be751-b34a-4004-b6a9-91aa8268a522

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DGQ	Whole Blood Plasma, Antigen, Antiserum, Control	Immunology	866.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42222	Sperm antibody IVD, control	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010518175	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			500 microliters per vial

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius