Immunoshop India Pvt Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 36 |
| Class B | Low–moderate risk | 402 |
| Class C | Moderate–high risk | 84 |
| Class D (high risk) | Highest-risk devices | 3 |
CDSCO device licences
"For the direct quantitative determination of dehydroepiandrosterone (DHEA) in human serum by an enzyme immunoassay."
IMP/IVD/2020/000833 · from Belgium"For the direct quantitative determination of Dihydrotestosterone by enzyme immunoassay in human serum."
IMP/IVD/2020/000833 · from Belgium"For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum."
IMP/IVD/2020/000833 · from BelgiumThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-TPO in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of thyroid-stimulating hormone (TSH) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-Müllerian hormone (AMH) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total triiodothyronine (Total T3) in human serum and plasma.
IMP/IVD/2025/000124 · from China"DIASpot Multiquant Neptune ANA25 Screen IgG is an Immunodot kit intended for the detection in human sera of IgG autoantibodies against Nucleosome, dsDNA, Histones, Sm, RNP (68kD/A/C), Sm/RNP, SSA/Ro 60kD, SSA/Ro 52kD, SSB, Scl-70, Ku, PM-S…
IMP/IVD/2020/000833 · from Belgium"For the direct quantitative determination of Cortisol by enzyme immunoassay in human serum."
IMP/IVD/2020/000833 · from BelgiumThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Total ? HCG in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of DHEA-S in human serum and plasma.
IMP/IVD/2025/000124 · from China"Immunoenzymetric assay for the in vitro quantitative measurement of human interleukin-6 (IL-6) in serum."
IMP/IVD/2020/000833 · from BelgiumImmunoenzymetric assay for the in vitro quantitative measurement of 1,25(OH)2 Vitamin D in serum.
IMP/IVD/2020/000833 · from BelgiumThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of 17?-OH Progesterone (17?-OH P) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Unconjugated Estriol (uE3) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-Tg in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of luteinizing hormone (LH) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Prolactin (PRL) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of TSH receptor antibodies (TRAb) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe Starter 1+2 is for triggering chemiluminescence reaction to produce the light signal, and it is used in conjunction with MAGLUMI assay reagents on the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series I…
IMP/IVD/2025/000124 · from ChinaThe Tip is an IVD accessory intended to be used with the MAGLUMI series Fully-auto Chemiluminescence Immunoassay Analyzer and Biolumi series Integrated System.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total thyroxine (Total T4) in human serum and plasma.
IMP/IVD/2025/000124 · from China"This test kit is intended for use in the quantitative determination of human calprotectin (neutrophil cytoplasmic protein S100A8/A9) levels in stool samples. The test is useful for detecting inflammatory bowel disease (IBD) such as ulcerat…
IMP/IVD/2020/000833 · from BelgiumImmunoenzymetric assay for the in vitro quantitative measurement of human Tumor Necrosis Factor ? (TNF-?) in serum.
IMP/IVD/2020/000833 · from BelgiumThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Free-Testosterone (F-T) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe Wash Concentrate is for the removal of substances which potentially interfere with the detection of signals, and it is used in conjunction with MAGLUMI assay reagents on the MAGLUMI series Fully-auto chemiluminescence immunoassay analyz…
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-TM in human serum and plasma
IMP/IVD/2025/000124 · from ChinaEnzyme Immunoassay for the quantitative determination of Metanephrine in urine
IMP/IVD/2020/000833 · from BelgiumThe Reaction Cup is an IVD accessory intended to be used with the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Thyroglobulin (TG) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Estradiol (E2) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaUsed in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of follicle stimulating hormone (FSH) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of free thyroxine (Free T4) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaImmunoenzymetric assay for the in vitro quantitative measurement of 25-hydroxyvitamin D2 and D3 (25OH-D2 and 25OH-D3) in serum.
IMP/IVD/2020/000833 · from BelgiumUsed in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.
IMP/IVD/2025/000124 · from ChinaThe Light Check is used for completing system test to monitor the status of MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Progesterone (PROG) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Testosterone (TEST) in human serum and plasma.
IMP/IVD/2025/000124 · from China"The DIAsource 17-OH Progesterone Enzyme Immunoassay Kit provides materials for the quantitative determination of 17-?-OH Progesterone in serum or plasma (EDTA-, heparin- or citrate plasma)."
IMP/IVD/2020/000833 · from BelgiumThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Rev T3 (rT3) in human serum and plasma.
IMP/IVD/2025/000124 · from ChinaInnovative Cartridge-based Specific Protein Analyzer.Fully automatic and quantitative analyzer
IMP/IVD/2020/000764 · from ChinaThe Chromatographic Column (HPLC) is intended for in vitro quantitative determination of glycated hemoglobin(HbA1c) content in human whole blood on the fully automated HPLC analyzer to aid diagnosis of diabetesmellitus.
IMP/IVD/2020/000338 · from ChinaThe kit is an in vitro chemiluminescent immunoassay for the simultaneously qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1(Group M and Group O), HIV-2 in human serum and plasma.
IMP/IVD/2020/000349 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Hepatitis A virus antibodies (Anti-HAV) in human Serum.
IMP/IVD/2020/000349 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the qualitative determination of HAV IgM in human serum.
IMP/IVD/2020/000349 · from ChinaThe kit is an in vitro chemiluminescence immunoassay for the quantitative determination of HBsAg in human serum and plasma.
IMP/IVD/2020/000349 · from ChinaThe kit is an In Vitro chemiluminescence immunoassay for the qualitative determination of Hepatitis C virus antibody (Anti-HCV) in human serum or plasma.
IMP/IVD/2020/000349 · from ChinaWan200+ Fully-automatic chemiluminescence Immunoass Analyzer (hereinafter referred to as the Analyzer) is produced by Xiamen United Medical Instruments Co., Ltd. The Analyzer is composed of sampling unit, analysis unit, computer, wireless k…
IMP/IVD/2023/000211 · from ChinaGlobal 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.