GenaCheck Vaginal pH Screening Test

Basic Information

• Brand Name: GenaCheck Vaginal pH Screening Test
• Primary DI: 00810143620016
• Version / Model: RA9-E02303
• Company Name: Genabio Diagnostics Inc.
• Labeler DUNS: 118586095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: 5830ba69-a08a-4401-8ff4-dd187b77a895

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LNW	Paper, Obstetric Ph	Clinical Chemistry	862.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58011	Vaginal pH screening 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 of vaginal secretions to determine pH range, within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to assess for pH imbalance resulting from potential bacterial or parasitic infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810143620016	GS1
Unit of Use	00810143620078	GS1