AQC AQC305

GUDID 00860010518182

Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 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 Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD Sperm morphology/viability control IVD
Primary Device ID00860010518182
NIH Device Record Keya5cba994-831a-490a-a2b1-122918aaf7ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQC
Version Model NumberAQC305
Catalog NumberAQC305
Company DUNS794781583
Company NameFertility Solutions, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com
Phone216-491-0030
Emailbusinessmgr@fertilitysolutions.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dark, dry place at 20-25 C

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010518182 [Primary]

FDA Product Code

LJGQuality Control Slides

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-23
Device Publish Date2024-04-15

On-Brand Devices [AQC]

08600105181752Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positi
00860010518175Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positi
00860010518182Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen
00860010518168Sperm Viability Quality Control. 2 stained and coverslipped sperm viability smears, 2 levels - a
00860010518151Sperm Morphology Quality Control - Unstained. 2 unstained, fixed, glass sperm morphology smears,
00860010518144Sperm Morphology Quality Control - Stained 2 Pap stained and coverslipped glass sperm morpholo
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.