Immunoassay Controls
- UID
- IMP/IVD/2023/000036_f1fc63ba636a39df34aa908268693d6d_de33f165e9ace27a3837082accdc4a2c
- Device class
- Class B
- Brand name
- MAGLUMI® Tip
- License holder
- SNIBE DIAGNOSTIC (India) Private Limited.
- Approving authority
- CDSCO
- Product information
- The Immunoassay Controls are intended for performing quality control procedures with MAGLUMI chemiluminescence immunoassay (MAGLUMI® Tip) assays when used for the quantitative determination of Total T3, Total T4, Free T3, Free T4, TSH, FSH, LH, Prolactin, Progesterone, Estradiol, Testosterone, Total HCG, Insulin and C-Peptide in human serum or plasma
Immunoassay Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000036_f1fc63ba636a39df34aa908268693d6d_de33f165e9ace27a3837082accdc4a2c. This device is marketed under the brand name MAGLUMI® Tip. The license holder is SNIBE DIAGNOSTIC (India) Private Limited., and it is classified as Device Class Class B. The approving authority is CDSCO.
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