BioCLIA Autoimmune Reagent Kit, GAD
Basic Information
- Primary DI
- 06924030415877
- Basic UDI-DI Code
- B-06924030415877
- Reference
- MY00142C
- 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, GAD assay is intended for the in vitro quantitative measurement of antibodies directed to GAD 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, GAD is intended for the calibration of the BioCLIA GAD performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, GAD is intended for the quality control purposes of the BioCLIA GAD 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
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