Neonatal Toxoplasma gondii IgM FEIA
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Basic Information
- Primary DI
- 06438172116016
- Basic UDI-DI Code
- B-06438172116016
- Reference
- 6199802
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
This Neonatal Toxoplasma gondii IgM FEIA kit is intended for the determination of IgM-class antibodies to Toxoplasma gondii in blood samples dried on filter paper. The test is intended as a primary method for screening of newborns for congenital toxoplasmosis (CT). Because IgM-class antibodies due to their high molecular weight do not cross placenta, determination of specific antibodies in newborn samples taken shortly after birth indicates exposure of the fetus intra utero to Toxoplasma gondii. Cases showing elevated levels of specific antibodies should be further investigated.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105050103 | TOXOPLASMA ANTIBODY IGM |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1172-794-22 | Eurofins Electric & Electronics Finland Oy | Expired |
Similar Devices
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