CDSCO UID MFG/IVD/2023/000073_c6ee0bfa5ea2d17f1f69f2ba7e3a2689_3ee458800e54d4a516a112be9860e40a
Folate ELISA Test Kit
Weldon Biotech India Pvt. Ltd.·Device Class Class B·India CDSCO
Registration details
- UID
- MFG/IVD/2023/000073_c6ee0bfa5ea2d17f1f69f2ba7e3a2689_3ee458800e54d4a516a112be9860e40a
- Device class
- Class B
- License holder
- Weldon Biotech India Pvt. Ltd.
- Approving authority
- Uttarakhand
- Product information
- The quantitative determination of Folate (NA) concentration in human plasma and serum samples. Microplate enzyme immunoassay provides the technical advantage of optimal accuracy, precision and sensitivity with fewer manipulations. Extracted sample (NA) are added to designated wells . A specific antibody to human Folate labeled with biotin is addedfollowed by an enzyme labelled folate solution. The enzyme labelled folate and endogenous folate compete for limited but specific sites on the antibody. After a predetermined incubation the microwells are washed to remove excess serum proteins and enzyme. A suitable substrate is added to generate inversely proportional color signal. From specified calibrator concentrations plotted on graph the Folate concentrations in the unknown samples can be interpolated. Folate Vitamin B-9 can be assayed in the range of more than three ng/ml using 50 μl serum samples
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About this record
Folate ELISA Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000073_c6ee0bfa5ea2d17f1f69f2ba7e3a2689_3ee458800e54d4a516a112be9860e40a. The license holder is Weldon Biotech India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttarakhand.
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