BioCLIA Autoimmune Reagent Kit, PM-Scl
Basic Information
- Primary DI
- 06924030415563
- Basic UDI-DI Code
- B-06924030415563
- Reference
- MY00107C
- 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, PM-Scl is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to PM-Scl in human serum and plasma as an aid in the diagnosis of anti-nuclear antibody (ANA) diseases including Systemic Lupus Erythematosus (SLE). It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, PM-Scl is intended for the calibration of the BioCLIA PM-Scl performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, PM-Scl is intended for the quality control purposes of the BioCLIA PM-Scl performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100199 | AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER |
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