UDC-Control - India CDSCO Medical Device Registration

UDC-Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000415_43f368b863a9178b7d3856b31651791f_e2aa2a7d339f6fa9ec1490365a96f12a. This device is marketed under the brand name Zybio. The license holder is Shree Enterprises, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

UDC-Control

UID: IMP/IVD/2022/000415_43f368b863a9178b7d3856b31651791f_e2aa2a7d339f6fa9ec1490365a96f12a

Brand Name

Zybio

License Holder

Shree Enterprises

Device Class

Class A

Approving Authority

CDSCO

Product Information

The product is applicable to the QC of the urine chemistry analyzer and urinalysis hybrid system. QC can be performed on analysis strips and instruments for 13 test items, i.e., urobilinogen (Zybio), bilirubin (Zybio), ketone (Zybio), leukocyte (Zybio), nitrite (Zybio), protein(Zybio),blood(Zybio),microalbumin(Zybio),creatinine (Zybio), glucose(Zybio), specific gravity (Zybio), pH, and calcium (Zybio)

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Hematology Analyser

Brand: Zybio

Epsilon Diagnostics

UDC-Control - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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