RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
Basic Information
- Primary DI
- 06977412420822
- Basic UDI-DI Code
- B-06977412420822
- Reference
- 50 test
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai Zymetas Medtech Co., Ltd
Additional Description
Tuberculosis IgG/IgM Rapid Detection Kit (Colloidal Gold) is a lateral flow immunoassay for the qualitative detection of IgG/IgM-class antibodies to Tuberculosis in serum, plasma or whole blood samples. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with Tuberculosis. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).