GoldN Easy to Use Vaginal pH Test
- Primary DI
- 00850059915882
- Brand
- GoldN Easy to Use Vaginal pH Test
- Company
- NOVODX Corporation
- Model
- GN041ST01-US
- Catalog number
- GN041ST
- Device description
- 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.
- Published
- 2025-01-10
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850059915882 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850059915882 | 00850059915882 | 850059915882 | 0850059915882 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vaginal pH screening IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the pH range of vaginal secretionse within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 2 Degrees Celsius | 30 Degrees Celsius | |
| Storage Environment Temperature | 2 Degrees Celsius | 30 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 119046376
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850059915370 | GoldN Easy to Use FSH Test | GN011ST02-US | GN011ST | 2025-01-24 |
| 00850059915639 | GoldN Easy to Use Pregnancy Test | GN040ST02-US | GN040ST | 2025-01-07 |
| 00850059915646 | GoldN Easy to Use Ovulation Test | GN013ST10-US | GN013ST | 2024-02-22 |
| 00850059915424 | GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC) | GN013ST | GN013ST25-US | 2024-02-23 |
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