GoldN Easy to Use Vaginal pH Test GN041ST

GUDID 00850059915882

The GoldN™ Easy to Use Vaginal pH Test is a fast pH value test of vaginal fluid specimens. The test is semi-quantitative for determination of vaginal pH range. It is designed for self-testing and in vitro diagnostic use to see if the vagina is under normal stage. The test is for use as an aid in the diagnosis of bacterial vaginosis. The intended population is women of menstruating age. It is intended for use by women who have any of the following symptoms: vaginal itching, vaginal burning or an abnormal color, odor, or excessive amount of vaginal discharge.

NOVODX Corporation

Vaginal pH screening IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 00850059915882
• NIH Device Record Key: 1e7c1782-0d2d-4cdd-9520-482e7c99b9a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldN Easy to Use Vaginal pH Test
• Version Model Number: GN041ST01-US
• Catalog Number: GN041ST
• Company DUNS: 119046376
• Company Name: NOVODX Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059915882 [Primary]

FDA Product Code

• CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)

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: 2025-01-20
• Device Publish Date: 2025-01-10

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• 00850059915882 - GoldN Easy to Use Vaginal pH Test: 2025-01-20 The GoldN™ Easy to Use Vaginal pH Test is a fast pH value test of vaginal fluid specimens. The test is semi-quantitative for d
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