BioCLIA Autoimmune Reagent Kit, ICA
Basic Information
- Primary DI
- 06924030415891
- Basic UDI-DI Code
- B-06924030415891
- Reference
- MY00144C
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- HOB Biotech Group Corp., Ltd.
Additional Description
The BioCLIA Autoimmune Reagent Kit, ICA assay is intended for the in vitro quantitative measurement of antibodies directed to ICA in human serum as an aid in the diagnosis of Insulin-dependent diabetes mellitus (IDDM), Type 1 in conjunction with other laboratory and clinical findings. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, ICA is intended for the calibration of the BioCLIA ICA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, ICA is intended for the quality control purposes of the BioCLIA ICA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102060105 | GAD II ANTIBODIES AND OTHER ICA |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).