Beta hCG FIA Test - India CDSCO Medical Device Registration
Beta hCG FIA Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000062_6e91ca48ceca494c16bcb91d15da5890_8faf9fc85a409847974651b2e43acf44. This device is marketed under the brand name hCG. The license holder is Mylab Discovery Solutions Pvt. Ltd. Lonavla, and it is classified as Device Class Class B. The approving authority is Pune Division.
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Brand Name
hCG
License Holder
Mylab Discovery Solutions Pvt. Ltd. LonavlaDevice Class
Approving Authority
Pune Division
Product Information
Beta hCG FIA Test is a fluorescence immunoassay for the determination of total Beta hCG levels in a human specimen using FIA Analyzers. This test is an in vitro diagnostic use test and is intended for professional testing and use as an aid in the early detection of pregnancy. More specific alternative diagnosis methods should be performed to obtain confirmation of pregnancy
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