Immunoassay Controls - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Immunoassay Controls

UID: IMP/IVD/2023/000036_f1fc63ba636a39df34aa908268693d6d_de33f165e9ace27a3837082accdc4a2c

Brand Name

MAGLUMI® Tip

License Holder

SNIBE DIAGNOSTIC (India) Private Limited.

Device Class

Class B

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

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Free-Testosterone (Maglumi Free-Testosterone )

Brand: MAGLUMI® Tip

SNIBE DIAGNOSTIC (India) Private Limited.

Immunoassay Controls - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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