Test Strips - India CDSCO Medical Device Registration

Test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_10cc801acdad1aa137b309d6dd561fc4_6a1d554cd522539174aed5debbef76b3. This device is marketed under the brand name SD Urocolor. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class B

Test Strips

UID: IMP/IVD/2020/000665_10cc801acdad1aa137b309d6dd561fc4_6a1d554cd522539174aed5debbef76b3

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

UroColor are plastic strips to which are attached several separate reagent areas. Depending on the product being used, UroColor provide tests for Blood, Bilirubin, Urobilinogen, Ketone, Protein, Nitrite, Glucose, pH, Specific gravity, Leucocytes and Ascorbic acid in Urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and urinary tract infection. It is intended only for use in a laboratory by a professional and in vitro diagnostic use. It can also be read instrumentally, using UroMeter* of Urine Chemistry Analyzer. *UroMeter 120/720

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Test Strips

Brand: Sanidex OPA Solution test strips

SIRMAXO CHEMICALS PVT.LTD.

Class A

Test Strips

Brand: Fora 6 Blood Glucose Test Strip, Fora 6 Blood Glucose, Hematocrit and Hemoglobin Test Strip, Fora 6 B-Ketone Test Strip, Fora 6 Total Cholesterol Test Strip, Fora 6 Uric Acid Test Strip

Globe Bio Medicals

Class B