SwimCount Sperm Quality Test

Basic Information

• Brand Name: SwimCount Sperm Quality Test
• Primary DI: 00843277100048
• Version / Model: 010116
• Company Name: Motilitycount ApS
• Labeler DUNS: 305237626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-17
• Public Version: 1
• Public Version Date: 2024-06-25
• Public Version Status: New
• Public Device Record Key: fc1bce3f-1b07-4c2f-9c59-afe1cc699b0d

Device Description

Sperm quality test

Device Characteristics

• Single Use: Yes
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POV	Semen Analysis Device	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61921	Motile sperm concentration IVD, kit, rapid colorimetric, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening for the concentration of progressive motile sperm in a semen specimen, using a rapid colorimetric method. This is a rapid test is intended to be used for self-testing by a layperson in the home or similar environment, for the assessment of male fertility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843277100048	GS1

Premarket Submissions

Submission Number	Supplement Number
K183602	000