ENTEROtest 24 - India CDSCO Medical Device Registration

ENTEROtest 24 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000060_fa21ae36d02532e43ee9252ce0d5b72b_b3444add34137b5b708a65d93cb2be31. 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

ENTEROtest 24

UID: IMP/IVD/2018/000060_fa21ae36d02532e43ee9252ce0d5b72b_b3444add34137b5b708a65d93cb2be31

Brand Name

Erba H360 Lyse

License Holder

M/s.Transasia Bio-Medicals Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

"The kit is intended for the routine identification of important species of family Enterobacteriaceae within 24 hours. "

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MedTech Regulatory Expert

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