THEO - India CDSCO Medical Device Registration
THEO is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_fe342adaac3d6cb07329207269db3829_84958a61d6050cb97229724b7755d1cb. This device is marketed under the brand name Antithrombin. The license holder is Roche Diagnostics India Pvt. 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.
Brand Name
Antithrombin
License Holder
Roche Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
In vitro diagnostic test for the quantitative determination of theophylline in serum or heparinized plasma on COBAS INTEGRA systems
SCC CalSet
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Combur 10 Test UX
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Elecsys CMV IgM
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Con 2
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Roche CARDIAC POC Troponin T 2-Level Control
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Blank Cal
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Total P1NP CalSet
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
DIBU
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
D Dimer Gen.2 Calibrator Set
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
HCG+beta Calset
Brand: Antithrombin
Roche Diagnostics India Pvt. Ltd.
Rovers ® Cervex-Brush
Brand: Rovers ® Cervex-Brush
cobas® MAI Positive Control Kit
Brand: cobas® MAI Positive Control Kit
cobas® Microbial Inactivation Solution (cobas® Microbial Inactivation Solution )-cobas® Microbial Inactivation Solution is to used in conjuction with cobas MTB/MAI/MTB RIF Nucleic acid test for use on the cobas® 6800/8800 Systems,cobas® Buffer Negative Control Kit
Brand: MIS
cobas® HCV
Brand: cobas® HCV
cobas® cfDNA Sample Preparation Kit
Brand: cobas® cfDNA Sample Preparation Kit
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0
Brand: cobas® HCV
MSwab® Collection, Preservation and Transport System
Brand: Copan MSwab® Collection, Preservation and Transport System
cobas b 101
Brand: cobas b 101
Aneuploidy and preeclampsia detection software
Brand: SsdwLab version 6
cobas t 411 coagulation analyzer
Brand: cobas t 411 coagulation analyzer