Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

IMMUNOGLOBULIN M

Changsha Sinocare Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-02B0028YX
Basic UDI-DI Code
B-02B0028YX
Reference
2S001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

Immunoglobulin (IgA/IgG/IgM) Reagent Kit is intended to quantitatively determine Immunoglobulin A (IGA), immunoglobulin G (IgG), immunoglobulin M (IgM) in human serum. Clinically, it is mainly used for the evaluation of immune function and auxiliary diagnosis of immune diseases. IgA accounts for 15% of soluble immunoglobulins, and serum IgA exists as monomers (about 90%), dimers or polymers. IgA elevation is usually accompanied by in IgA multiple myeloma, systemic lupus erythematosus, rheumatoid arthritis, liver cirrhosis, eczema and diseases and etc.. IgA concentration is associated with inflammation in the context of toxic liver injury. The reduction in IgA is co seen in respiratory tract infection, primary and secondary immunodeficiency diseases, autoimmune diseases and metabolic diseases. IgG is the most abundant immunoglobulin produced by plasma cells, accounting for 75% of the total immunoglobulin. The decrease in IgG concentration occurs in various congenital and acquired immunodeficiency diseases, metabolic diseases, hyperthyroidism and malnutrition. As a marker of immune response, elevated IgG is commonly seen in various chronic infections, chronic liver diseases and autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis and etc.. IgM is one of the earliest immunoglobulins, which is produced as a body's first response to an antigen and accounts for 5% of the total immunoglobulin in adult serum. The decrease in IgM concentration occurs in primary and secondary immunodeficiency syndrome, protein loss, intestinal diseases or burning, which its increase is seen in severe infections, autoimmune diseases, macroglobulinemia, bacterial and parasitic diseases, liver diseases, rheumatoid arthritis and gallbladder fibrosis.

CND Nomenclature Codes

Code Description
W0102010107 IMMUNOGLOBULIN M
W0102010105 IMMUNOGLOBULIN G
W0102010101 IMMUNOGLOBULIN A

Similar Devices

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).

View all