ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST
Basic Information
- Primary DI
- 06936155804535
- Basic UDI-DI Code
- B-06936155804535
- Reference
- ITP03004-DS50
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- InTec PRODUCTS, INC.
Additional 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 relativesymptom; 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 sextransmitted diseases (STD's) among high-risk group of people, regular healthexaminations, and field screen test for blood bank.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090105 | SYPHILIS - RT & POC |
Similar Devices
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