Vaginal pH Rapid Test Cassette (Vaginal Secretions)

Trade name

Vaginal pH Rapid Test Cassette (Vaginal Secretions)

UDI-DI code

D-VPH-502aL8

Basic UDI-DI

B-VPH-502aL8

Reference / catalog number

VPH-502a

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Vaginal pH Rapid Test Cassette (Vaginal Secretions) is a pH rapid test for the determination of vaginal fluid acidity in human vaginal fluid specimens. The vaginal determination of the pH is a very useful screening parameter as it is an indication for most clinical and subclinical vaginal infections. This kit is intended for use as an aid 1. in the diagnosis or prevention of possible vaginal infections in both pregnant and not pregnant women and 2. to provide the physician for a clinical reference and increase chances of a successful pregnancy. The test is designed for professional in vitro diagnostic use. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105070501STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS

1 warning recorded — scroll inside the panel to see all entries.

• CW007

  Do not use test if pouch is damaged

No certificate specifically references this device's Basic UDI-DI.