Diagnostic Biosystems USA Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 20 |
| Class B | Low–moderate risk | 591 |
| Class C | Moderate–high risk | 92 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin- embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-¬?fixed, paraffin-¬? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompan…
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed,paraffin embedded tissue sections to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied…
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe Mouse/Rabbit PolyVue Plus? HRP/DAB Detection System is a non?biotin, two?step detection system suitable for labeling antigens in formalin?fixed paraffin?embedded tissues and cryostat sections. The PolyVue Plus? Detection System may also…
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin- embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied…
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThis product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin- embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied…
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin?fixed, paraffin? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompanied …
IMP/IVD/2020/000910 · from United StatesThe product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-¬?fixed, paraffin-¬? embedded tissue sections, to be viewed by light microscopy. Clinical interpretation of staining results should be accompan…
IMP/IVD/2020/000910 · from United StatesCalibrator reagent solution used to calibrate the Hematology instrument.
IMP/IVD/2020/000948 · from HungaryReagents used to measure the blood components level in human blood using an Hematology instrument.
IMP/IVD/2020/000948 · from HungaryControl material used along with reagent pack to measure the blood components in Hematology instrument.
IMP/IVD/2020/000948 · from HungaryReagent cleaning solution used to clean the inner parts of the Hematology instrument.
IMP/IVD/2020/000948 · from HungaryControl material used along with reagent pack to measure the blood components in Hematology instrument.
IMP/IVD/2020/000948 · from HungaryControl material used along with reagent pack to measure the blood components in Hematology instrument.
IMP/IVD/2020/000948 · from HungaryControl material used along with reagent pack to measure the blood components in Hematology instrument.
IMP/IVD/2020/000948 · from HungaryIt is intended to be used for quantitative measurement of electrolytes and/or other ions such as Sodium, Potassium, Chloride, Calcium in human serum or plasma.
MFG/IVD/2020/000128 · Tamil NaduIt is intended to be used to quantify the formed elements in animal blood (i.e., erythrocytes, leukocytes, and platelets) by electroimpedance and colorimetry.
MFG/IVD/2020/000128 · Tamil NaduIt is intended to be used for the quantitative determination of multiple clinical chemistry analytes in a specimen serum.
MFG/IVD/2020/000128 · Tamil NaduIt is indented to be used for the calibration of a Vitamin D test kit by quantitative determination system
MFG/IVD/2020/000128 · Tamil NaduIt is indented to be used for the calibration of a Vitamin D test kit by quantitative determination system
MFG/IVD/2020/000128 · Tamil NaduIt is intended to be used to quantify the formed elements in blood (i.e., erythrocytes, leukocytes, and platelets) by electroimpedance and colorimetry.
MFG/IVD/2020/000128 · Tamil NaduVitamin D Test Kit is used for quantitative in vitro determination of 25-Hydroxy Vitamin D in human serum on photometric systems.
MFG/IVD/2020/000128 · Tamil NaduThe ISE module urine diluent is used to dilute urine samples prior to analysis.
IMP/IVD/2025/000138 · from United StatesThe pack is intended for use to calibrate the Na, K, Cl & Li sensors. It contains buffered Calibrant & a waste container to collect waste.
IMP/IVD/2025/000138 · from United StatesUsed to establish the performance of electrolyte analysers using controls.
IMP/IVD/2025/000138 · from United StatesUsed to monitor the performance of the Easylyte analyser
IMP/IVD/2025/000138 · from United StatesUsed to remove the protein deposits from the fluid and the sensor path on the ISE Module.
IMP/IVD/2025/000138 · from United StatesConcepta Viral Transport Media Kits are a formulated medium for collection and transportation of clinical specimens containing viruses from the collection center to the laboratory.
MFG/IVD/2020/000128 · Tamil NaduThe oxalate control urine is intended for quality control in the laboratory only and is supplied with suggested intervals of acceptable values. For in vitro professional use in the clinical laboratory only
IMP/IVD/2019/000428 · from SpainUrine strips for the measurement of Microalbumin and Creatinine in urine.
IMP/IVD/2020/000845 · from South KoreaUrine strips for the measurement of Glucose, Proteins, Ketones, pH, Urobilinogen, Leucocytes, Nitrite, Bilirubin, Specific Gravity and Blood in urine.
IMP/IVD/2020/000845 · from South KoreaUrine strips for the measurement of Glucose and Proteins in urine.
IMP/IVD/2020/000845 · from South KoreaUrine strips for the measurement of Glucose, Proteins, Ketones, pH, Urobilinogen, Leucocytes, Nitrite, Bilirubin, Specific Gravity and Blood in urine.
IMP/IVD/2020/000845 · from South KoreaBeing used to standardize the Microalbuminurea kit
IMP/IVD/2019/000428 · from SpainReagents for measurement of a amylase EPS concentration in serum.
IMP/IVD/2019/000428 · from SpainReagents for measurement of alkaline phosphatase AMP concentration in serum
IMP/IVD/2019/000428 · from SpainReagents for measurement of a amylase pancreatic concentration in serum.
IMP/IVD/2019/000428 · from SpainReagents for measurement of microalbuminurea concentration in serum, plasma, Urine
IMP/IVD/2019/000428 · from SpainGlobal 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.