AQC

Basic Information

• Brand Name: AQC
• Primary DI: 00860010518151
• Version / Model: AQC205
• Catalog Number: AQC205
• Company Name: Fertility Solutions, Inc.
• Labeler DUNS: 794781583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-15
• Public Version: 1
• Public Version Date: 2024-04-23
• Public Version Status: New
• Public Device Record Key: dd5c7830-616e-4f19-ae02-77ef1ff94a34

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

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJG	Quality Control Slides	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67049	Sperm morphology/viability control IVD	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010518151	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dark, dry place at 20-25 C