Great Basin Bordetella Direct Test
Basic Information
- Primary DI
- D-888501395GBBordVC
- Basic UDI-DI Code
- B-888501395GBBordVC
- Reference
- 300782
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The Great Basin Bordetella Direct Testis a qualitative in vitro diagnostic test for the detection of Bordetella pertussis DNA from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis. It identifies the insertion sequence IS481 of Bordetella Pertussis genome. Negative results for the Great Basin Bordetella Direct Test do not preclude B. pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Great BasinBordetella Direct Test should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in the diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Bordetella Direct Test Cartridge Kit.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011607 | BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS |
Similar Devices
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