Diasorin Healthcare India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 14 |
| Class B | Low–moderate risk | 273 |
| Class C | Moderate–high risk | 188 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
LIAISON® EASY System Liquid ([REF] 319302) is required on the LIAISON® XS Analyzer as a system liquid and for rinsing the pipetting needle of the LIAISON® XS Analyzer.
IMP/IVD/2023/000297 · from United KingdomIn vitro assay for the quantitative determination of IGF-I (Insulin-like Growth Factor I) in human serum. The test has to be performed on the LIAISON® Analyzer family*.*(LIAISON®, LIAISON® XL and LIAISON® XS)
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control HBeAg (Negative and Positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® HBeAg assay. The performance characteristics of LIAISON® HBeAg controls have n…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Anti-HBc controls (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® Anti-HBc assay. The performance characteristics of LIAISON® Anti-HBc contr…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of prolactin in human serum and plasma. The test has to be performed on the LIAISON® Analyzer family*.*(LIAISON®, LIAISON® XL, LIAISON® XS)
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Insulin assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of insulin in human serum or EDTA-plasma specimens. The test has to be performed on the LIAISON® Analyzer family.
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Biotrin Parvovirus B19 IgG controls (negative and positive) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® Biotrin …
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Borrelia IgG assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of specific IgG antibodies to Borrelia burgdorferi sensu lato (including strains Borrelia burgdorferi sensu strictu, Bor…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Anti-HBc assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of total antibodies to Hepatitis B core Antigen (Anti-HBc) in human serum and plasma samples included specimens collected post…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® XL MUREX Anti-HBs assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human serum or plasma samples. Assay results in conjunctio…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® VZV IgM assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative determination of specific IgM antibodies to varicella-zoster virus (VZV) in human serum and plasma samples. This assay is intended a…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® MUREX Anti-HEV IgG assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of IgG antibodies to hepatitis E virus (Anti-HEV IgG) in human serum and plasma samples. The assay is intended to e…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® MUREX Anti-HEV IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgM antibodies to hepatitis E virus (Anti-HEV IgM) in human serum and plasma samples, including specimens collect…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of autoantibodies against thyroid peroxidase (TPO) in human serum as well as in EDTA, citrated and heparinised human plasma. The test has to be performed on the LIAISON® Analyzer family*. *(…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of alpha-fetoprotein (AFP) in human serum as well as in EDTA and heparinised human plasma or amniotic fluid for pregnancy monitoring and during the follow-up of tumour patients. The test has…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Biotrin Parvovirus B19 IgG assay uses chemiluminescence immunoassay (CLIA) technology for the qualitative determination of specific IgG antibodies to parvovirus B19 in human serum or plasma samples. The test has to be performe…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® EA IgG assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of specific IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum or plasma samples.The test has t…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Borrelia IgM II assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative determination of specific IgM antibodies to Borrelia burgdorferi sensu lato (including strains Borrelia burgdorferi sensu st…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® HBeAg assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Hepatitis B e Antigen (HBeAg) in human serum and plasma samples. The assay is intended as an aid in the diagnosis of HBV infe…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Borrelia IgM Quant assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro quantitative determination of specific IgM antibodies to Borrelia burgdorferi sensu lato (including strains Borrelia burgdorferisensu…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® MUREX Control Anti-HEV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX Anti-HEV IgG assay. The performance characteristics of LIAISON®MUREX Ant…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® XL MUREX Anti-HBs controls (negative and positive) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking the reliability of assay runs. The performance characteristics of LIAISON® XL MUREX Anti…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of carcinoembryonic antigen (CEA) in human serum as well as in EDTA or heparinised human plasma during the follow-up of cancer patients. The test has to be performed on the LIAISON® Analyzer…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of human chorionic gonadotropin (hCG and ?hCG) in human serum. The test has to be performed on the LIAISON® Analyzer family*.*(LIAISON®, LIAISON® XL and LIAISON® XS)
IMP/IVD/2025/000151 · from ItalyThe LIAISON® MUREX Control Anti-HEV IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® MUREX Anti-HEV IgM assay. The performance characteristics of LIAISON® MUREX An…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Borrelia IgG and Borrelia IgG Liquor controls (negative and positive) are to be used in LIAISON®chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON®…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control Borrelia IgM Quant / Borrelia IgM II (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® Borrelia IgM Quant / Borrelia IgM II assays. Th…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control CMV IgG Avidity II (Low and High) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® CMV IgG Avidity II assay. The performance characteristics of LIAISON® CMV …
IMP/IVD/2025/000151 · from ItalyThe LIAISON® EA IgG controls (negative and positive) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® EA IgG controls have not bee…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control HBc IgM controls (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® HBc IgM assay. The performance characteristics of LIAISON® HBc IgMc…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® XL MUREX Anti-HBs assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human serum or plasma samples. Assay results in conjunctio…
IMP/IVD/2025/000151 · from ItalyThe HBsAg Confirmatory Test is an in vitro neutralization assay for confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples found repeatedly reactive for HBsAg by LIAISON® XL MUREX HBsAg Quant (…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Insulin controls (level 1 and level 2) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® Insulin controls have not bee…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control VZV IgM (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® VZV IgM assay. The performance characteristics of LIAISON® VZV IgM controls …
IMP/IVD/2025/000151 · from ItalyThe LIAISON® HBc IgM assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgM antibodies to Hepatitis B core Antigen (HBc IgM) in human serum and plasma samples. The assay is intended as an aid in t…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of ferritin in human serum and plasma. The test has to be performed on the LIAISON® Analyzer family*.*(LIAISON®, LIAISON® XL, LIAISON® XS)
IMP/IVD/2025/000151 · from ItalyThe LIAISON® fPSA controls (low and high) are to be used in LIAISON® fPSA chemiluminescent immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® Control fPSA have not been establis…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® hGH controls (level 1 and level 2) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® hGH controls have not been establ…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control Anti-HAV (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® Anti-HAV assay. The performance characteristics of LIAISON® Anti-HAV contro…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Cleaning Kit is useful to improve routine maintenance of the LIAISON® system. It intervenes to clean the pipettor and the washer needles, contributing to guarantee complete serviceability of the Starter reagent pumps. The kit c…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Chlamydia trachomatis IgG assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro semi-quantitative determination of specific IgG antibodies to Chlamydia trachomatis in human serum or plasma samples. The assa…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of cortisol in human serum, plasma (and urine). The test has to be performed on the LIAISON® Analyzer family*.*(LIAISON®, LIAISON® XL and LIAISON® XS)
IMP/IVD/2025/000151 · from ItalyThe LIAISON® EASY Cleaning Tool is useful to improve routine maintenance of the LIAISON® XL and LIAISON® XS analyzers. It intervenes to clean the following instrument parts: ?washer needles and tubes on the LIAISON® XL Analyzer. ?washer nee…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Chlamydia trachomatis IgA assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative determination of specific IgA antibodies to Chlamydia trachomatis in human serum or plasma samples. The assay is i…
IMP/IVD/2025/000151 · from ItalyIn vitro assay for the quantitative determination of autoantibodies against thyroglobulin (Tg) in human serum as well as in EDTA and heparinised human plasma. The test has to be performed on the LIAISON® Analyzer family*. *(LIAISON®, LIAISO…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Anti-HAV assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV) in human serum or plasma samples. The assay is intended as an aid in the d…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Treponema Screen assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of specific total antibodies to Treponema pallidum in human serum or plasma samples. The test has to be performed on t…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control Chlamydia trachomatis IgG (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® Chlamydia trachomatis IgG assay. The performance character…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® QuantiFERON®-TB Gold Plus controls (level 1 and level 2) are to be used in LIAISON® chemiluminescence immunoassays (CLIA) as a means of checking reliability of assay runs. The performance characteristics of LIAISON® QuantiFERON…
IMP/IVD/2025/000151 · from ItalyThe LIAISON® Control Chlamydia trachomatis IgA (negative and positive) are intended for use as assayed quality control samples to monitor the performance and reliability of LIAISON® Chlamydia trachomatis IgA assay. The performance character…
IMP/IVD/2025/000151 · from ItalyGlobal footprint
Cross-railThe same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.
No FDA clearances linked — India-domestic footprint.
Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.