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Rapid Immunochromatographic Assay for detection of IgM antibodies to HEV in human serum/plasma(INSIGHT HEV IgM ) - India CDSCO Medical Device Registration

Rapid Immunochromatographic Assay for detection of IgM antibodies to HEV in human serum/plasma(INSIGHT HEV IgM ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000047_8645605b869f6fbdd435b7c14756bb8f_dfa429905e6a53976807d0d7764d6e7f. This device is marketed under the brand name DEVICE. The license holder is ORCHID BIOMEDICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Goa.

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CDSCO Registered
Class Class B
Rapid Immunochromatographic Assay for detection of IgM antibodies to HEV in human serum/plasma(INSIGHT HEV IgM )
UID: MFG/IVD/2020/000047_8645605b869f6fbdd435b7c14756bb8f_dfa429905e6a53976807d0d7764d6e7f

Brand Name

DEVICE

Device Class

Class B

Approving Authority

Goa

Product Information

Insight HEV IgM is a rapid immunochromatographic assay for the detection of IgM antobodies to Hepatitis E Virus in human serum/plasma

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