SPINTROL “H” NORMAL - India CDSCO Medical Device Registration

SPINTROL “H” NORMAL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000126_f95670eb31f328123de0e250d3c4dc59_7dab17c55905b7c5643b0620a9f9414f. This device is marketed under the brand name Beta 2 –MICROGLOBULIN TURBI. The license holder is INDO-MIM TEC 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

SPINTROL “H” NORMAL

UID: IMP/IVD/2022/000126_f95670eb31f328123de0e250d3c4dc59_7dab17c55905b7c5643b0620a9f9414f

Brand Name

Beta 2 –MICROGLOBULIN TURBI

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Multiparametric control sera intended for accuracy control of clinical chemistry reagents. The concentrations and activities are in the normal range (Beta 2 –MICROGLOBULIN TURBI)

DJ Fang

MedTech Regulatory Expert

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