CDSCO UID MFG/IVD/2020/000043_8c902253279df1365c6631035df12f7f_ccdac90104fb2edf9169897bb5e059a0

Rapid Test System for the detection of Dengue NS1 Antigen and IgG/IgM antibodies to Dengue Virus in Human Serum/Plasma (DENGUCHECK COMBO )

ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: CA 15-3
Registration details
UID
MFG/IVD/2020/000043_8c902253279df1365c6631035df12f7f_ccdac90104fb2edf9169897bb5e059a0
Device class
Class C
Brand name
CA 15-3
Approving authority
Sub Zonal Goa
Product information
Dengucheck Combo is intended for the detection of Dengue NS-1 antigen and IgG/IgM antibodies to Dengue virus. The test system can be used for screening of Dengue viral infection and as an aid for differential diagnosis of the self limiting primary Dengue infections and the potentially fatal secondary Dengue infections in conjunction with other criteria
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About this record

Rapid Test System for the detection of Dengue NS1 Antigen and IgG/IgM antibodies to Dengue Virus in Human Serum/Plasma (DENGUCHECK COMBO ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_8c902253279df1365c6631035df12f7f_ccdac90104fb2edf9169897bb5e059a0. This device is marketed under the brand name CA 15-3. The license holder is ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.

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