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CDSCO UID IMP/IVD/2018/000038_ffbd381e4192ff2430ffbc48c593c755_1f4015798c0fb122ba94a137e59dd053

Lupus S

Roche Diagnostics India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: Calset Vitamin D Total III
Registration details
UID
IMP/IVD/2018/000038_ffbd381e4192ff2430ffbc48c593c755_1f4015798c0fb122ba94a137e59dd053
Device class
Class B
Brand name
Calset Vitamin D Total III
License holder
Roche Diagnostics India Pvt. Ltd.
Approving authority
CDSCO
Product information
In vitro assays to screen for (Calset Vitamin D Total III) and to confirm (Calset Vitamin D Total III) the presence of lupus anticoagulants in citrated plasma on the indicated cobas t analyzers. The assay is intended as an aid in the diagnosis of anti phospholipid syndrome
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About this record

Lupus S is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_ffbd381e4192ff2430ffbc48c593c755_1f4015798c0fb122ba94a137e59dd053. This device is marketed under the brand name Calset Vitamin D Total III. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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