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CDSCO UID MFG/IVD/2022/000071_6f45f39340dc93699a9d03b31f8df8db_6d3a61f7f3f2dabc6d796b2f79a9eb03

Dengue IgG/IgM Uncut Sheet-The Dengue IgG/IgM uncut sheet is the raw material intended for further manufacturing of rapid immunochromatography assay for the qualitative detection and differentiation of the IgG and IgM antibodies against Dengue virus in human whole blood/ serum/ plasma samples.,hCG Uncut Sheet-The hCG uncut sheet is the raw material intended for further manufacturing of rapid immunochromatography assay for the qualitative detection of human chorionic gonadotropin in human urine samples to aid in the early detection of pregnancy.,hCG Rapid Test

LABGENE BIO-TECH PRIVATE LIMITED·Device Class Class B·India CDSCO·Brand: conjugated
Registration details
UID
MFG/IVD/2022/000071_6f45f39340dc93699a9d03b31f8df8db_6d3a61f7f3f2dabc6d796b2f79a9eb03
Device class
Class B
Brand name
conjugated
License holder
LABGENE BIO-TECH PRIVATE LIMITED
Approving authority
Gujarat
Product information
The “EVASPECT” (conjugated) kit is a rapid immunochromatography assay for the qualitative detection of human chorionic gonadotropin (conjugated) in human urine samples to aid in the early detection of pregnancy. In-vitro diagnostic medical devices for self-testing Human Chorionic Gonadotropin (conjugated).,hCG Rapid Test(conjugated)-The “Zoxx” (conjugated) kit is a rapid immunochromatography assay for the qualitative detection of human chorionic gonadotropin (conjugated) in human urine samples to aid in the early detection of pregnancy. In-vitro diagnostic medical devices for self-testing Human Chorionic Gonadotropin (conjugated).
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Chikungunya IgG/IgM Uncut sheet-The Chikungunya IgG/IgM uncut sheet is the raw material intended for further manufacturing of rapid immunochromatography assay for the qualitative detection and differentiation of the IgG and IgM antibodies against Chikungunya virus in human whole blood/ serum/plasma samples.,hCG Rapid Test
Brand: conjugated
LABGENE BIO-TECH PRIVATE LIMITED
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About this record

Dengue IgG/IgM Uncut Sheet-The Dengue IgG/IgM uncut sheet is the raw material intended for further manufacturing of rapid immunochromatography assay for the qualitative detection and differentiation of the IgG and IgM antibodies against Dengue virus in human whole blood/ serum/ plasma samples.,hCG Uncut Sheet-The hCG uncut sheet is the raw material intended for further manufacturing of rapid immunochromatography assay for the qualitative detection of human chorionic gonadotropin in human urine samples to aid in the early detection of pregnancy.,hCG Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000071_6f45f39340dc93699a9d03b31f8df8db_6d3a61f7f3f2dabc6d796b2f79a9eb03. This device is marketed under the brand name conjugated. The license holder is LABGENE BIO-TECH PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Gujarat.

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