Arkray Healthcare Pvt., Ltd.,
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 29 |
| Class B | Low–moderate risk | 312 |
| Class C | Moderate–high risk | 51 |
| Class D (high risk) | Highest-risk devices | 45 |
CDSCO device licences
It is used to dissolve red blood cells and release hemoglobin before analysis, so as to count white blood cells and determine hemoglobin concentration. The reagent is intended for human sample testing
IMP/IVD/2026/000039 · from ChinaThis product is applicable for detecting the parameters of WBC, RBC, PLT, HGB, etc. in anti-coagulated venous whole blood or capillary blood, as well as WBC 3-part differential analysis and WBC counting.Please consult company first if you w…
IMP/IVD/2026/000039 · from ChinaIt is used for blood cell analysis , sample dilution and cell suspension preparation before analysis. The reagent is intended for human sample testing
IMP/IVD/2026/000039 · from ChinaTo analyze the parameters of urine components
IMP/IVD/2019/000339 · from ChinaTo analyze the parameters of urine components
IMP/IVD/2019/000339 · from ChinaWashing solution concentration used for washing the flow lines, measuring section, and measurement sensor after the loaded samples are measured.
IMP/IVD/2020/000801 · from JapanThis Standard solution is intended for the use as the exclusive standard solution of Arkray, Inc's Osmotic pressure analyzers.
IMP/IVD/2020/000801 · from JapanDetermination of Glucose, Protein, Bilirubin, Urobilinogen, Creatinine, pH, Blood, Ketones, Nitrite and?Leukocytes in urine.
IMP/IVD/2020/000675 · from JapanConcentrated Washing Solution 3 used for cleaning the nozzle and tubing of fully-automatic AUTION analyzers, which is a concentrate 10 fold-concentration
IMP/IVD/2020/000801 · from JapanDILUENT 90 is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. This set dissolves and dilutes commercially available freeze-dried controls specified by your distributor and dilute…
IMP/IVD/2020/000801 · from JapanELUENT 90CV-S is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. for in vitro diagnostic use only
IMP/IVD/2020/000801 · from JapanCALIBRATOR 90 is intended for calibration for ADAMS A1c H-8190V.
IMP/IVD/2020/000801 · from JapanHEMOLYSIS WASHING SOLUTION 90H is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. Use this product to dilute whole blood samples, and wash the tubes in which sample flows. For In…
IMP/IVD/2020/000801 · from JapanCOLUMN UNIT 90 is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. for in vitro diagnostic use only
IMP/IVD/2020/000801 · from JapanELUENT 90A is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. for in vitro diagnostic use only.
IMP/IVD/2020/000801 · from JapanELUENT 90B is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. for in vitro diagnostic use only.
IMP/IVD/2020/000801 · from JapanELUENT 90CV is intended for the determination of Hemoglobin A1c (HbA1c) in human whole blood for use with ADAM A1c HA-8190V. for in vitro diagnostic use only
IMP/IVD/2020/000801 · from JapanAUTION EYE Sheath Solution is used for determination of formed elements in human urine
IMP/IVD/2020/000801 · from JapanTo detect the glucose, ketone, SG, Blood, PH, protein, nitrite, bilirubin, urobilinogen and leukocyte in urine
IMP/IVD/2019/000339 · from ChinaTo detect the glucose, protein, PH and SG in urine
IMP/IVD/2019/000339 · from ChinaTo detect the glucose, ascorbic acid, ketone, SG, Blood, PH, protein, nitrite, bilirubin, urobilinogen and leukocyte in urine
IMP/IVD/2019/000339 · from ChinaTo detect the glucose and ketone in urine
IMP/IVD/2019/000339 · from ChinaTo detect the glucose and protein in urine
IMP/IVD/2019/000339 · from ChinaTo detect the glucose, ketone, SG, Blood, PH, protein, nitrite, bilirubin, urobilinogen and leukocyte in urine
IMP/IVD/2019/000339 · from ChinaSignal® HIV 3D+ is an in vitro qualitative screening test for differential detection of HIV-1 (including Group O) and HIV-2 infection using human serum or plasma. The assay is intended for use by skilled healthcare workers / laboratory pr…
MFG/IVD/2019/000025Immunochromatographic one step rapid visual test for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) and paratyphi IgG and IgM antibodies in Human Serum, Plasma or Whole Blood ? Device. The assay is intend…
MFG/IVD/2019/000061 · Gujarat"TrinScreen? HIV test is a single use, rapid immunoassay for the qualitative detection of antibodies to human immunodeficiency virus type 1 and 2 in serum, plasma, and whole blood (venipuncture and fingerstick). The test is for in vitro dia…
MFG/IVD/2019/000025Uni-GoldTM HIV is a single use rapid immunoassay, for the qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma and whole blood (venipuncture and fingerstick). Uni-Gold HIV is intended for use in point of care settings as …
MFG/IVD/2019/000025Uni-GoldTM HIV is a single use rapid immunoassay, for the qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma and whole blood (venipuncture and fingerstick). Uni-Gold HIV is intended for use in point of care settings as …
MFG/IVD/2019/000025For quantitatively measuring the glucose level in fresh capillary whole blood
MFG/IVD/2019/000025Crystal® Dengue NS1 is an in vitro rapid qualitative screening test for detection of Dengue NS1 antigen in human serum, plasma or whole blood. This test is intended for use by skilled Health Care Workers / Laboratory Professionals to aid in…
MFG/IVD/2019/000025Diagnostic reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube tests
MFG/IVD/2019/000061 · GujaratPocketChem Vita-D Quantitative Vitamin D Test is an immunochromatography- based one step in vitro test. It is designed for the quantitative determination of total 25-hydraxy Vitamin D (25-OH Vitamin D) in human finger-prick blood. This assa…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® Liquid Gold Lactate Dehydrogenase (LDH) is an in vitro quantitative determination of Lactate Dehydrogenase (LDH) in human serum. Fully automated and semi-automated analysers are required to perform this test. This kit is intended …
MFG/IVD/2019/000061 · GujaratDiagnostic reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube tests.
MFG/IVD/2019/000061 · GujaratDiagnostic reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube tests
MFG/IVD/2019/000061 · GujaratGLUCOCARD Sigma Test Strips are for quantitatively measuring the glucose level in fresh capillary whole blood. They are intended for use outside of the body (in vitro diagnostic use) at home or in a clinical setting as an aid to monitor and…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® ALP (Alkaline Phosphatase) is used for an in vitro quantitative determination of ALP (Alkaline Phosphatase) in human serum / plasma. Fully automated and semi automated analysers are required to perform this test. This kit is inten…
MFG/IVD/2019/000061 · GujaratImmunochromatographic test for qualitative detection of Yersinia pestis antigen is an in vitro qualitative screening test to diagnose plague, using human serum / plasma / bubo aspirates / sputum swab sample or samples suspended in Cary Blai…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® Turbi Gold® HbA1c Direct test kit with Direct Calibrator set is an in vitro quantitative determination of Haemoglobin A1c (HbA1c) in human blood for evaluation of glycemic control in diabetes mellitus. It provides indication of g…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® Liquid Gold Lactate Dehydrogenase (LDH) is an in vitro quantitative determination of Lactate Dehydrogenase (LDH) in human serum. Fully automated and semi-automated analysers are required to perform this test. This kit is intended …
MFG/IVD/2019/000061 · GujaratDiagnostic reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube tests
MFG/IVD/2019/000061 · GujaratCRP (C-Reactive Protein ) Latex Test Kit is used as in vitro Qualitative and semi-quantitative latex slide test to detect CRP. This kit is intended to be used by trained laboratory professionals
MFG/IVD/2019/000061 · GujaratThe ASO Antistreptolysin ?O? Latex Test Kit is latex agglutination assay for the qualitative and semi quantitative detection of antistreptolysin antibodies (ASO) in human serum. It is intended for in vitro diagnostics use by trained healt…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® Urea is used for an in vitro quantitative determination of Urea in human serum / plasma and urine. Fully automated, semi-automated photometric analysers are required to perform this test. This kit is intended to be used by trained…
MFG/IVD/2019/000061 · GujaratDiagnostic Reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube test.
MFG/IVD/2019/000061 · GujaratAUTOSPAN Liquid Gold Total Protein is used for an in vitro quantitative determination of Total Protein in human serum / plasma. Fully automated, semi automated photometric analysers, spectrophotometer and colorimeter are required to perform…
MFG/IVD/2019/000061 · GujaratAUTOSPAN® Liquid Gold Urea is used for an in vitro quantitative determination of Urea in human serum / plasma and urine. Fully automated and semi-automated photometric analyzers are required to perform this test. This test is intended to be…
MFG/IVD/2019/000061 · GujaratDiagnostic reagents for the in vitro detection and quantitative estimation of specific antibodies to Salmonella present in serum by rapid slide and conventional tube tests.
MFG/IVD/2019/000061 · GujaratGlucocard G+ (meter), Glucocard G+ Link (meter) and Glucocard G+ Test Strips are for quantitatively measuring the glucose level in fresh capillary whole blood. They are intended for use outside of the body (in vitro diagnostic use) at home…
MFG/IVD/2019/000061 · GujaratGlobal 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.