SD BIOLINE H.Pylori - India CDSCO Medical Device Registration

SD BIOLINE H.Pylori is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000156_2ac917debedc1f09b54245aec261f812_4b7104a16a25daefa5f2e082cf94ea1d. This device is marketed under the brand name SD BIOLINE Dengue IgG/IgM WB. 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

SD BIOLINE H.Pylori

UID: IMP/MD/2018/000156_2ac917debedc1f09b54245aec261f812_4b7104a16a25daefa5f2e082cf94ea1d

Brand Name

SD BIOLINE Dengue IgG/IgM WB

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SD BIOLINE H. pylori kit is a rapid, qualitative test for the detection of antibodies to Helicobacter pylori in human serum and plasma. The SD BIOLINE H. pylori kit is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA (SD BIOLINE Dengue IgG/IgM WB)