SD Biosensor Healthcare Pvt. Ltd
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 20 |
| Class B | Low–moderate risk | 363 |
| Class C | Moderate–high risk | 279 |
| Class D (high risk) | Highest-risk devices | 51 |
CDSCO device licences
To make testing sample by dissolving the specimen in this buffer.
IMP/IVD/2021/000025 · from South KoreaSTANDARD F LH FIA is an fluorescent immunoassay to measure LH level in human serum, plasma, and whole blood. The quantitative measurement of the LH helps evaluate fertility issues, function of reproductive organs (ovaries or testicles), to …
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer.
IMP/IVD/2021/000025 · from South KoreaTo make the buffer and the specimen reactive
IMP/IVD/2021/000025 · from South KoreaSTANDARD F Vitamin D FIA is an in vitro diagnostic for the quantitative measurement of total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum and plasma. This test provides a preliminary diagnostic test result and can be used for scree…
IMP/IVD/2021/000025 · from South KoreaIt is the fluorescence immunoassay to detect adenovirus infection in human nasal swab and nasopharyngeal swab, identifying existence of adenovirus. STANDARD F Adeno Respi Ag FIA should be used with the STANDARD F Analyzers manufactured by S…
MFG/MD/2018/000005STANDARD F Vitamin D Control is designed to monitor the performance of STANDARD F Vitamin D FIA and STANDARD F Analyzer. To maintain the testing quality, at least two levels of appropriate control reagents should be tested on a regular basi…
IMP/IVD/2021/000025 · from South KoreaIt is an in vitro diagnostic use to qualitative measure the C. difficile Toxin A/B in feces. This is only for professional use. It provides only an initial screening test result. STANDARD F C. difficile Toxin A/B FIA should be used with the…
MFG/MD/2018/000005STANDARD Ezi tube+ is disposable plastic capillary pipet, used to collect and transfer the precise volume of the blood from human for POCT and rapid testing. For professional use only.
IMP/IVD/2021/000025 · from South KoreaIt is a fluorescence immunoassay for the qualitative detection of S. pneumoniae CPS Ag present in urine samples from patients with respiratory symptoms and in cerebral spinal fluid (CSF) samples from patient with meningitis. This test is fo…
MFG/MD/2018/000005To collect the specimen with this Spoit and to make the specimen, extraction buffer and tablet in the Spoit mixed.
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer.
IMP/IVD/2021/000025 · from South KoreaTo make the buffer and the specimen reactive.
IMP/IVD/2021/000025 · from South KoreaThe STANDARD F U-Albumin FIA is an in vitro diagnostic use to measure the albumin in the urine from the human. This test is for professional use to measure U-Albumin to aid to predict the diabetic nephropathy and cardiovascular diseases (CV…
IMP/IVD/2021/000025 · from South KoreaIt is an immunochromatographic assay for the detection of Wuchereria bancrofti antigens in human serum, plasma or whole blood samples.
IMP/IVD/2021/000025 · from South KoreaThe STANDARD LipidoCare Analyzer is designed to measure the quantitative measurement of the blood parameters: Total Cholesterol(?TC?), Triglycerides(?TG?), High-Density Lipoprotein Cholesterol(?HDL?), calculated ?LDL?, ?LDL/HDL?, ?non-HDL?.…
IMP/IVD/2021/000025 · from South KoreaGlucoNavii® PRO BT Blood Glucose Meter and accessories work together to measure the amount of glucose (sugar) in your blood. Your GlucoNavii® PRO BT Blood Glucose Monitoring System is indicated for monitoring glucose in fresh capillary wh…
IMP/IVD/2021/000025 · from South KoreaIt is a rapid immunochromatographic test that utilizes a membrane-based system for the qualitative detection of Plasmodium falciparum (P. falciparum) specific Histidine Rich Protein 2 (HRP-2) and Plasmodium falciparum (P. falciparum) specif…
IMP/IVD/2023/000567 · from South KoreaIt is a rapid immunochromatographic test that utilizes a membrane-based system for the qualitative detection of Plasmodium falciparum (P. falciparum) specific Histidine Rich Protein 2 (HRP-2)/ Plasmodium lactate dehydrogenase (pLDH), and Pl…
IMP/IVD/2023/000567 · from South KoreaSTANDARD F Syphilis Ab FIA is a fluorescence immunoassay for the qualitative detection of anti-syphilis from human serum, plasma or whole blood. The test is for in vitro diagnostic use and intended as an aid to early diagnosis of syphilis i…
MFG/MD/2018/000005STANDARD F Ferritin FIA is an in vitro diagnostic use to measures the Ferritin in human serum and EDTA plasma. The quantity measurement of the Ferritin is used in diagnosing and monitoring iron deficiency or overload condition.
MFG/IVD/2025/000045 · HaryanaVitamin D test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids. or ULTRA F Vitamin D FIA is an in vitro diagnostic for the quantitative measurement of total 25-hydroxy Vitamin D (25-OH Vitamin D…
MFG/IVD/2025/000045 · HaryanaIt is an in vitro diagnostic system for the quantitative measurement of creatine kinase-MB (CK-MB) in human serum and plasma. This fully automated chemiluminescence immunoassay is designed for use on STANDARD? i analyzers. The test provides…
MFG/IVD/2020/000017 · HaryanaULTRA F Progesterone is tested using the competition assay method for the quantitative determination of progesterone levels in human serum using ULTRA F Analyzers, manufactured by SD BIOSENSOR. It is beneficial for aiding in the monitoring …
MFG/IVD/2025/000045 · HaryanaIt is an in vitro diagnostic system for the quantitative measurement of creatine kinase-MB (CK-MB) in human serum and plasma. This fully automated chemiluminescence immunoassay is designed for use on ULTRA i analyzers. The test provides C…
MFG/IVD/2020/000017 · HaryanaIt is an in vitro diagnostic system for quantitative measurement of prolactin (PRL) in human serum and plasma. This fully automated chemiluminescence immunoassay is designed for use on ULTRA i analyzers. The test provides prolactin values…
MFG/IVD/2020/000017 · HaryanaSTANDARD F Progesterone is tested using the competition assay method for the quantitative determination of progesterone levels in human serum using STANDARD F Analyzers, manufactured by SD BIOSENSOR. It is beneficial for aiding in the monit…
MFG/IVD/2025/000045 · HaryanaDengue Antibody test kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids. or STANDARD F Dengue IgM/IgG FIA is a ?uorescence immun…
MFG/IVD/2025/000045 · HaryanaVitamin D test reagent/kit is a medical device intended for the estimation of Vitamin B in blood/body fluids. or STANDARD F Vitamin D FIA is an in vitro diagnostic for the quantitative measurement of total 25-hydroxy Vitamin D (25-OH Vitami…
MFG/IVD/2025/000045 · HaryanaULTRA F Ferritin FIA is an in vitro diagnostic use to measures the Ferritin in human serum and EDTA plasma. The quantity measurement of the Ferritin is used in diagnosing and monitoring iron deficiency or overload condition.
MFG/IVD/2025/000045 · HaryanaChikungunya Antibody test kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids or ULTRA F Chikungunya IgM/IgG FIA is a ?uorescence immuno…
MFG/IVD/2025/000045 · HaryanaDengue Antibody test kit is a medical device intended for the detection of Dengue Antibody in blood/body fluids. or ULTRA F Dengue IgM/IgG FIA is a ?uorescence immunoassay f…
MFG/IVD/2025/000045 · HaryanaChikungunya Antibody test kit is a medical device intended for the detection of Chikungunya Antibody in blood/body fluids or STANDARD F Chikungunya IgM/IgG FIA is a ?uore…
MFG/IVD/2025/000045 · HaryanaIt is an in vitro diagnostic system for quantitative measurement of prolactin (PRL) in human serum and plasma. This fully automated chemiluminescence immunoassay is designed for use on STANDARD i analyzers. The test provides prolactin valu…
MFG/IVD/2020/000017 · HaryanaIt is an immunochromatographic assay for the detection of IgM/IgG antibodies against Leptospira bacteria in human serum, plasma, or whole blood specimens. This test kit is for in vitro diagnostic use only. This is intended for professional …
MFG/IVD/2025/000045 · HaryanaIt is an in vitro diagnostic use to measure Blood glucose, designed for self-testing blood glucose using the fresh capillary whole blood from the finger tip.
IMP/IVD/2021/000025 · from South KoreaTo apply extracted specimen to the specimen well of the test device.
IMP/IVD/2021/000025 · from South KoreaTo collect the specimen with this Spoit and to make the specimen, extraction buffer and the tablet in the Spoit mixed.
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer.
IMP/IVD/2021/000025 · from South KoreaSTANDARD F Tsutsugamushi IgM/IgG Test is a fluorescent immunoassay for the detection of IgM/IgG antibodies against Orientia tsutsugamushi in human serum, plasma, or whole blood samples. This test kit is for in vitro use only. This is inte…
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer
IMP/IVD/2021/000025 · from South KoreaIt is intended for use as a quality control material to check the Performance of Standard F hs-CRP FIA and Standard F Analyzers.
IMP/IVD/2021/000025 · from South KoreaSTANDARD F TnI FIA is a ?uorescence immunoassay for the quantitative determination of total Troponin I (cTnI) levels in human serum and whole blood using STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is an in vitro diagnostic…
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer.
IMP/IVD/2021/000025 · from South KoreaSTANDARD F hsCRP FIA is an in vitro diagnostic use to measures the CRP in the human serum, plasma, and whole blood sample. The measurement of CRP provides information for the detection and evaluation of infection, tissue injury, inflammato…
IMP/IVD/2021/000025 · from South KoreaIt is designed to monitor the performance of STANDARD H. Pylori Ag control and STANDARD F Analyzer.
IMP/IVD/2021/000025 · from South KoreaSTANDARD F NT-proBNP FIA is an in vitro diagnostic use to measure the N-terminal pro b-type natriuretic peptide (NT-proBNP) in serum, plasma, and whole blood. The quantitative measurement of the NT-proBNP is useful in the diagnosis of acute…
IMP/IVD/2021/000025 · from South KoreaTo make testing sample by dissolving the specimen in this buffer
IMP/IVD/2021/000025 · from South KoreaGlobal 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.