FSH Test - India CDSCO Medical Device Registration
FSH Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000062_ac2de8f3a56279f65230475155fad89b_060816ae9c6e12ea3e64d84074f5fd7b. 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
The FSH Test is a chromatographic immunoassay for the qualitative detection of Follicle-stimulating hormone (hCG) levels in urine to evaluate the onset of menopause in women. This test is for in-vitro professional diagnostic use as well as for home test use. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of FSH present in the specimen
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