AQC AQC205

GUDID 00860010518151

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

Fertility Solutions, Inc.

Sperm morphology/viability control IVD

• Primary Device ID: 00860010518151
• NIH Device Record Key: dd5c7830-616e-4f19-ae02-77ef1ff94a34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQC
• Version Model Number: AQC205
• Catalog Number: AQC205
• Company DUNS: 794781583
• Company Name: Fertility Solutions, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry place at 20-25 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010518151 [Primary]

FDA Product Code

• LJG: Quality Control Slides

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

On-Brand Devices [AQC]

• 08600105181752: Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positi
• 00860010518175: Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positi
• 00860010518182: Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen
• 00860010518168: Sperm Viability Quality Control. 2 stained and coverslipped sperm viability smears, 2 levels - a
• 00860010518151: Sperm Morphology Quality Control - Unstained. 2 unstained, fixed, glass sperm morphology smears,
• 00860010518144: Sperm Morphology Quality Control - Stained 2 Pap stained and coverslipped glass sperm morpholo