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 table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850059915882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059915882008500599158828500599158820850059915882

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal pH screening IVD, kit, rapid colorimetric, clinicalA 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 table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
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 table
Primary DIBrandModelCatalogPublished
00850059915370GoldN Easy to Use FSH TestGN011ST02-USGN011ST2025-01-24
00850059915639GoldN Easy to Use Pregnancy TestGN040ST02-USGN040ST2025-01-07
00850059915646GoldN Easy to Use Ovulation TestGN013ST10-USGN013ST2024-02-22
00850059915424GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC)GN013STGN013ST25-US2024-02-23

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