ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

Trade name

ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

UDI-DI code

06936155804528

Basic UDI-DI

B-06936155804528

Reference / catalog number

ITP03004-TC40

Issuing entity

GS1

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

The One Step Anti-TP (Treponema Pallidum /Syphilis) Test is a rapid, serological, immunochromatographic assay for the detection of antibodies to syphilis antigen in human whole blood, serum or plasma. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision. The test is used to obtain a visual, qualitative result and is intended for healthcare professional use. Applications of the test include: screen test for sex transmitted diseases (STD’s) among high-risk group of people, regular health examinations. The test uses a double-antigen sandwich immunochromatographic principle for the detection of syphilis antibodies in human whole blood, serum or plasma. During the assay, syphilis antibodies in the specimen react with colloidal gold-labelled syphilis antigen and migrate along the membrane by capillary action. If syphilis antibodies are present, the immune complex is captured by recombinant syphilis antigen immobilized in the test region, forming a visible colored test band. The control band serves as a procedural control and indicates that the test has been performed properly.

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.

• W0105090105SYPHILIS - RT & POC

5 warnings recorded — scroll inside the panel to see all entries.

• CW009

  Do not re-use the test cards or any single-use accessories.
• CW007

  Do not use the test cards if they have become wet or if the foil pouch is damaged.
• CW032

  Do not use kit materials beyond their expiration dates.
• CW011

  For in vitro diagnostic use only. All positive results must be confirmed by an alternate method. Do not interchange reagents from one kit lot to another, use only suitable specimens, avoid cross-contamination, and do not interpret results after 20 minutes.
• CW010

  Read and follow the package insert carefully before use.; Biological risks: Handle all specimens in accordance with Biosafety Level 2 practices. Treat whole blood, serum or plasma specimens as infectious material, wear gloves and protective clothing, disinfect spills with a suitable disinfectant, and sterilize used devices before disposal.

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