BioCLIA Autoimmune Reagent Kit, IAA
Basic Information
- Primary DI
- 06924030415822
- Basic UDI-DI Code
- B-06924030415822
- Reference
- MY00133C
- 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, IAA assay is intended for the in vitro semi-quantitative measurement of insulin autoantibody (IAA) in human serum as an aid in the diagnosis of insulin-dependent diabetes mellitus (IDDM), latent autoimmune diabetes of adults (LADA) or other related disorders 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, IAA is intended for the calibration of the BioCLIA IAA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, IAA is intended for the quality control purposes of the BioCLIA IAA performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102060199 | DIABETES ASSAYS - OTHER |
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