Pure Global
CDSCO UID IMP/IVD/2021/000420_9bf328119ef8686e610696a43b5d7a69_b4a0314262dc6667b93fac61babac3c7

D-Dimer

M/S Agappe Diagnostics Ltd·Device Class Class C·India CDSCO·Brand: Electro chemiluminescence Immunoassay
Registration details
UID
IMP/IVD/2021/000420_9bf328119ef8686e610696a43b5d7a69_b4a0314262dc6667b93fac61babac3c7
Device class
Class C
Brand name
Electro chemiluminescence Immunoassay
License holder
M/S Agappe Diagnostics Ltd
Approving authority
CDSCO
Product information
Immunoassay for in vitro quantitative determination of D-Dimer in human plasma, which is mainly used for the elimination of venous thrombosis, the auxiliary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolytic therapy
Similar products (10)
Other products with the same name or brand
D-Dimer
PARIKSHA BIOTECH PRIVATE LIMITED
Class B
D-Dimer
Brand: CLIA
Star Biomed Pvt. Ltd.
Class C
D-Dimer
Brand: eCLIA
Q-Line Biotech Private Limited (Formerly Known As POCT SERVICES PRIVATE LIMITED)
Class C
Creatine Kinase MB
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class C
Lipoprotein-Associated Phospholipase A2
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class C
Troponin I
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class C
Vitamin B12
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class B
Parathyroid Hormone
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class B
Anti-Mullerian Hormone
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class B
Ferritin
Brand: Electro chemiluminescence Immunoassay
M/S Agappe Diagnostics Ltd
Class B
Other products from M/S Agappe Diagnostics Ltd
Products from the same license holder (10 products)
Nucleic Acid Amplification and Detection Analyzer
Class A
AUTOMATED BIOCHEMICAL ANALYZER
Brand: TBA-120FR
Class A
Fully Automatic Chemiluminescence immunoassay Analyzer
Brand: Mispa i700
Class A
Coated Uncut Sheets for Dengue IgG/IgM
Class C
Coated Uncut sheet for Dengue NS1
Class C
Hemoglobin analyzer
Brand: Mispa HBX
Class A
5- Part Hematology Analyzer
Brand: Mispa Count Plus
Class A
Automatic Chemiluminescence Analyzer
Class A
Auto Biochemistry Analyzer
Brand: Mispa Count X Plus
Class A
Auto Hematology Analyzer - 3 Part
Brand: Mispa Count X Plus
Class A
About this record

D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_9bf328119ef8686e610696a43b5d7a69_b4a0314262dc6667b93fac61babac3c7. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.