BioCLIA Autoimmune Reagent Kit, CTD Screen
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Basic Information
- Primary DI
- 06924030405281
- Basic UDI-DI Code
- B-06924030405281
- Reference
- MY00969
- 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, CTD Screen assay is intended for the in vitro semi-quantitative measurement of autoantibodies to Sm, dsDNA, Nucleosome, Histone, Ribosomal-P, PCNA, Ro60, Ro52, SS-B/La, Scl-70, Jo-1, PM/Scl, CENP-B, nRNP/Sm and AMA-M2 in human serum and plasma on the fully automatic BioCLIA instrument. The kit is applied as an aid in the diagnosis of connective tissue diseases such as Sjögren's syndrome, systemic lupus erythematosus (SLE), CREST syndrome, Systemic Sclerosis, Polymyositis/Dermatomyositis, Primary Biliary Cirrhosis and so forth. It is an in vitro diagnostic medical device intended for laboratory professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100101 | ANA SCREENING |
Similar Devices
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