BioCLIA Autoimmune Reagent Kit, IA2
Basic Information
- Primary DI
- 06924030415884
- Basic UDI-DI Code
- B-06924030415884
- Reference
- MY00143C
- 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, IA2 assay is intended for the in vitro quantitative measurement of antibodies directed to IA2 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, IA2 is intended for the calibration of the BioCLIA IA2 performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, IA2 is intended for the quality control purposes of the BioCLIA IA2 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102060106 | THYROSIN PHOSPHATASE IA2 ANTIBODIES |
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