Urinalysis Reagent Strips - India CDSCO Medical Device Registration

Urinalysis Reagent Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000250_153974250cae9145a311f412b8d559de_f3a3bb2a6f8fc4de9eec0a3afe9e34c4. This device is marketed under the brand name Urine. The license holder is Accurex Biomedical 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

Urinalysis Reagent Strips

UID: IMP/IVD/2022/000250_153974250cae9145a311f412b8d559de_f3a3bb2a6f8fc4de9eec0a3afe9e34c4

Brand Name

Urine

License Holder

Accurex Biomedical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Urinalysis Reagent Strips (Urine) are fi rm plastic strips onto whichseveral separate reagent areas are affi xed. The test is for the qualitativeand semi quantitative detection of one or more of the followinganalytes in urine: Ascorbic acid, Creatinine Microalbumin , Glucose Bilirubin, Ketone Acetoacetic acid, Specifi c Gravity, B lood, pH, Protein Urobilinogen, Nitrite and Leukocytes, Calcium . The Urinalysis ReagentStrips (Urine) are for single use in professional near patient (Urine) and centralized laboratory locations.