JE IgM ELISA(JE Detect IgM Antibody Capture ELISA ) - India CDSCO Medical Device Registration

JE IgM ELISA(JE Detect IgM Antibody Capture ELISA ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000145_e1dab7a18c38c4c440d8b2f9d9d5c92a_04e380ce43c09bda84c0a20337f9be6c. This device is marketed under the brand name Scrub Typhus Detect IgG ELISA. The license holder is SIRUS BIOCARE PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

JE IgM ELISA(JE Detect IgM Antibody Capture ELISA )

UID: IMP/IVD/2019/000145_e1dab7a18c38c4c440d8b2f9d9d5c92a_04e380ce43c09bda84c0a20337f9be6c

Brand Name

Scrub Typhus Detect IgG ELISA

License Holder

SIRUS BIOCARE PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The JE Detect IgM ELISA (JE Detect™ IgM Antibody Capture ELISA (Scrub Typhus Detect IgG ELISA)) test for exposure to Japanese Encephalitis Virus (Scrub Typhus Detect IgG ELISA) is an ELISA assay system for the detection of IgM antibodies in human serum to JEVderived recombinant antigen