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Basic Information
- Primary DI
- 05060169694002
- Basic UDI-DI Code
- 5060169694002WT
- Reference
- IS-AI1703
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS GBM test is an automated in vitro diagnostic device intended for the quantitative determination of specific IgG class antibodies directed against the Glomerular Basement Membrane (GBM) in samples of human serum or plasma (EDTA, Na-citrate) on the IDS-iSYS Mulit-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician as an aid in the evaluation of Goodpasture’s syndrome and for differential diagnosis of vasculitides.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102109014 | ANTIBODIES TO GLOMERULAR BASAL MEMBRANE |
Available In Countries
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