CDSCO UID MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0DURAClone B27 Reagent Kit
- UID
- MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0
- Device class
- Class B
- Brand name
- DURAClone B27 Reagent Kit
- License holder
- Beckman Coulter India Private Limited
- 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.
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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