AQC AQC109

GUDID 00860010518175

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

Fertility Solutions, Inc.

Sperm antibody IVD, control

• Primary Device ID: 00860010518175
• NIH Device Record Key: 725be751-b34a-4004-b6a9-91aa8268a522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQC
• Version Model Number: AQC109
• Catalog Number: AQC109
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010518175 [Primary]

FDA Product Code

• DGQ: Whole Blood Plasma, Antigen, Antiserum, Control

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: 2023-11-07
• Device Publish Date: 2023-10-30

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