ASPEN DIAGNOSTICS PVT. LTD.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 59 |
| Class B | Low–moderate risk | 436 |
| Class C | Moderate–high risk | 38 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
This reagent is applied to the invitro quantitive measurement of creatinine concentration of human serum, plasma or urine.
IMP/IVD/2026/000032 · from China2 ITEMS (GLU, KET) Reagent Strips for Urinalysis is used for qualitative and semi-quantitative test of ketone (acetoacetic acid) and glucose in urine.
IMP/IVD/2026/000032 · from ChinaClinical Chemical Quality Control serum includes Level 1 and Level 2, used for the quality control of clinical analysis determination of many biochemical items.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of creatine kinase (CK) activity of human serum or plasma. CK is the dipolymerase comprised by two monomer subunits of M (muscle) mode and B (brain) mode. M mode combines with …
IMP/IVD/2026/000032 · from ChinaThe reagent is used for the in vitro quantitative measurement of cystatin C content in human serum or plasma. Cystatin C is a secreted protein, widely present in various body fluids, such as cerebrospinal fluid, blood, saliva, semen. Study …
IMP/IVD/2026/000032 · from China1 ITEM (GLU) Reagent Strips for Urinalysis is used for qualitative and semi-quantitative test of glucose in urine.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of activity of cholinsterase in human serum or plasma. Serum cholinesterase comes from the liver. Under the circumstance of acute and chronic hepatitis, hypoalbuminemia, its ac…
IMP/IVD/2026/000032 · from ChinaTo clean the refractometer and turbidimeter of H Series Urine Analyzer, FUS Series Urinalysis Hybrid and MUS Series Urinalysis System.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to in vitro quantitative determination of complement 4 content in human serum. Complement C4 is an important component of complement classical pathway. Its determination helps the diagnosis, treatment and etiology of…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of activity of CK-MB isoenzyme in human serum . CK is the dipolymerase comprised by two monomer subunits of M (muscle) mode and B (brain) mode. M mode combines with B mode mono…
IMP/IVD/2026/000032 · from ChinaClinical Chemical Calibration Serum includes Level 1 and Level 2, used for the calibration of clinical analysis determination of many biochemical items.
IMP/IVD/2026/000032 · from ChinaFor cleaning reagent probe, reaction cuvette and soaking reaction cup of the CS series Auto-Chemistry Analyzer.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitive measurement of the concentration of D-bilirubin (DB) of human serum.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of D-bilirubin concentration of human serum or plasma.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of total bile acid concent in human serum. Human total bile acid library in the day is relatively balanced. Daily bile acid is mainly excreted through feces, balance takes chol…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitive determination of total cholesterol concentration in human serum. Serum cholesterol determination can be used as indicator to diagnose liver function, biliary function, intestinal absorption,…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of chloride concentration of human serum, plasma. Chloride is the major extracellular anion. The blood chloride level changes with sodium concentration changes in the circums…
IMP/IVD/2026/000032 · from ChinaUsed to clean ISE electrode of CS series Auto-Chemistry Analyzer.
IMP/IVD/2026/000032 · from ChinaIt is used for cleaning and rinsing of tubing system. It will effectively clean the remained urine and other test-interfering particles to avoid cross-contamination among urine sample.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to in vitro quantitative determination of complement 3 content in human serum. The complement system is composed of at least 20 kinds of plasma protein and several kinds of receptor proteins, through the enzymatic ca…
IMP/IVD/2026/000032 · from ChinaIt is used for the in vitro quantitative detection of the content of the copper in human serum.
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative determination of calcium concentration of serum, plasma or urine. Calcium has many functions in the human body. In addition to be the material element of bone and teeth, it also has the fu…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaFor cleaning sample probe and reaction cuvette of CS series Auto-Chemistry Analyzer.
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative determination of carbon dioxide content in human serum or plasma. The test of carbon dioxide content is mainly used for auxiliary diagnosis of diabetic acidosis, severe diarrhea, shock, ki…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative determination of calcium concentration of serum, plasma or urine. Calcium has many functions in the human body. In addition to be the material element of bone and teeth, it also has the fu…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the in vitro quantitive determination of the activity of Alpha-hydroxybutyrate dehydrogenase (Alpha ?HBDH) in serum or plasma. This method is selective method for type I isoenzyme of lactate dehydrogenase, which i…
IMP/IVD/2026/000032 · from ChinaThe reagent is used for the in vitro quantitative measurement of 5?- nucleotidase activity in human serum or plasma. 5?-nucleotidase is a enzyme that catalyze nucleotide -5?- monophosphate, and hydrolyze into nucleotide and inorganic phosph…
IMP/IVD/2026/000032 · from ChinaThis reagent is used for the in vitro quantitative measurement of adenosine deaminase activity in human serum or plasma.
IMP/IVD/2026/000032 · from ChinaIt is used for in vitro quantitative detection of the activity of Alpha-L-fucosidase in human serum or plasma.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitive measurement of the activity of ALT in human serum. ALT Activity Increase Hepatobiliary disease: infectious hepatitis, toxic hepatitis, fatty liver and cholangitis, etc. Cardiovascular diseas…
IMP/IVD/2026/000032 · from ChinaThis reagent is for the invitro quantitative determination of albumin concentrotion in human serum or plasma. Albumin is the major plasma protein. Its main functions include adjusting the distribution of extracellular liquid; transporting i…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitive measurement of the activity of alkaline phosphatase in human serum or plasma Alkaline phosphatase is a group of non- specific phosphatase. They catalyze the same type of biochemical reaction…
IMP/IVD/2026/000032 · from ChinaThe reagent kit is used for the in vitro quantitative detection of the content of Alpha 1-MG in human serum samples. Serum ?1-MG can sensitively reflect the changes in glomerular filtration function. Under normal circumstances, about 99.9% …
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the in-vitro quantitative determination of a-amylase activity of human serum or urine a-amylase is mainly from salivary gland and exocrine gland, and catalyze the hudrolysis of amylum and other related a-1, 4 gly…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the in vitro quantitative determination of anti- streptolysin O in human serum. Streptolysin O is one of the metabolites of A hemolytic streptococci. It is a protein with hemolytic activity and antigenicity. A hem…
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of apolipoprotein A1 (APO A1) content of human serum.
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of apolipoprotein B (Apo B) content of human serum .
IMP/IVD/2026/000032 · from ChinaThis reagent is applied to the invitro quantitative measurement of aminotransferase (AST) activity in human serum or plasma.
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaFor the cleaning and rinsing of the tubing system.
IMP/IVD/2026/000032 · from ChinaThe product is a fully automated instrument for quantitative analysis of chemical components in human samples (including serum, plasma, urine, cerebrospinal fluid, hydrothorax and ascites), which can assist in the diagnosis of normal people…
IMP/IVD/2026/000032 · from ChinaDIRUI 2 ITEMS (PRO, GLU) Reagent Strips for Urinalysis is used for qualitative and semiquantitative test of protein and glucose in urine.
IMP/IVD/2026/000032 · 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.