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CDSCO UID MFG/IVD/2020/000043_9ec675aa33459330869d6df285edf66c_e6f0dfe5e8f8a61201e1cca4502a80ee

Fluorescence Immunoassay for Quantitative Determination of D-Dimer in Human Plasma

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_9ec675aa33459330869d6df285edf66c_e6f0dfe5e8f8a61201e1cca4502a80ee
Device class
Class C
Brand name
CA 15-3
License holder
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED
Approving authority
Sub Zonal Goa
Product information
FIACHECK D-Dimer Fluorescence Immunoassay is intended for the in-vitro quantitative measurement of D-Dimer in human plasma
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Products from the same license holder (10 products)
Rapid Test for Malaria Pv/Pf
Brand: CA 15-3
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Rapid Test for Malaria PAN
Brand: CA 15-3
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Rapid Test for Syphilis (SYPHICHECK )
Brand: CA 15-3
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Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
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Brand: CA 15-3
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Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma
Brand: CA 15-3
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Chemiluminescence Assay for the Quantitative Determination of Ovarian Cancer Antigen in Human Serum
Brand: CA 15-3
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Enzyme Linked Immunosorbent Assay for the Quantitative Determination of Breast Cancer Antigen in Human Serum
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Fluorescence Immunoassay for Quantitative detection of Cardiac Troponin I in Human Serum/Plasma
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About this record

Fluorescence Immunoassay for Quantitative Determination of D-Dimer in Human Plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_9ec675aa33459330869d6df285edf66c_e6f0dfe5e8f8a61201e1cca4502a80ee. 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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