RNA Extraction Kit with Carrier RNA for RT-PCR Testing - India CDSCO Medical Device Registration

RNA Extraction Kit with Carrier RNA for RT-PCR Testing is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000029_f3bd34ae071305d7f21741a67d5e7309_1fd59e0f44a0e791cbc077a3413715ed. This device is marketed under the brand name HbChek Control Set. The license holder is CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is Goa.

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CDSCO Registered

Class Class A

RNA Extraction Kit with Carrier RNA for RT-PCR Testing

UID: MFG/IVD/2022/000029_f3bd34ae071305d7f21741a67d5e7309_1fd59e0f44a0e791cbc077a3413715ed

Brand Name

HbChek Control Set

License Holder

CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED

Device Class

Class A

Approving Authority

Goa

Product Information

This kit is recommended to be used for the isolation of viral RNA from various samples like fresh and frozen plasma, serum, nasopharylngeal swab, orpharylngeal swab, sputum, broncho-alveolar lavage in viral transport medium and other body fluids. The system is intended for use by professional users trained in molecular biological techniques