Reagent for INDOLtest - India CDSCO Medical Device Registration

Reagent for INDOLtest is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000060_dd3dd65462d3d5ebbbc2a40fc7f9393e_916c0c54b2ce17e3a12265667ccf75ff. This device is marketed under the brand name Erba H360 Lyse. The license holder is M/s.Transasia Bio-Medicals Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Reagent for INDOLtest

UID: IMP/IVD/2018/000060_dd3dd65462d3d5ebbbc2a40fc7f9393e_916c0c54b2ce17e3a12265667ccf75ff

Brand Name

Erba H360 Lyse

License Holder

M/s.Transasia Bio-Medicals Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

"A supplementary colour forming reagent for the test for indol production, used for the set of tests of diagnostic Microbiology kits."

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MedTech Regulatory Expert

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