DURAClone B27 Reagent Kit - India CDSCO Medical Device Registration
DURAClone B27 Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0. This device is marketed under the brand name DURAClone B27 Reagent Kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.
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Brand Name
DURAClone B27 Reagent Kit
License Holder
Beckman Coulter India Private LimitedDevice Class
Approving Authority
Karnataka
Product Information
The DuraClone B27 reagent is comprised of a two-color, immunofluorescence stain, suitable for detecting the HLA-B27 antigen expression in human whole blood samples using a lyse, no wash protocol on a flow cytometer. This reagent is not intended for use to determine the HLA-B27 tissue group.
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