AccessGUDID - DEVICE: AQC (08600105181752)

GUDID

Device Identifier (DI) Information

Brand Name: AQC
Version or Model: AQC109
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AQC109
Company Name: Fertility Solutions, Inc.

Primary DI Number: 08600105181752
Issuing Agency: GS1
Commercial Distribution End Date: October 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 794781583 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGQ	Whole Blood Plasma, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 500 microliters per vial

Device Record Status

Public Device Record Key: cd26caa4-74d6-4d0e-8678-8be30d99b120
Public Version Date: October 31, 2023
Public Version Number: 2
DI Record Publish Date: September 15, 2023