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Rapid / CLIA/ ELISA Kits approved for testing of Covid-19 with the conditions.

Following firms have been approved for manufacture of Kits for testing Covid-19 as on 22/05/2020

S. No. Name of the Firm Type of Kit Country
1.

M/s CPC Diag. Pvt.

Ltd, Chennai

Chemiluminscent
Immuno Assay IgG & IgM (CLIA)

CE       Approved        and      in Australia

M/s         Shenzhen     YHLO

Biotech Co. Ltd. China
2

M/s                       Eris

LifeSciences, Ahmedabad
Florescent, IgG & IgM

M/s Maccure Biotechnology .Ltd. China

CE      Approved       and     in China
3

M/s                   Cadila

Healthcare      Ltd, Ahmedabad
Antibody rapid test IgG/IgM

M/s. Hangzhou Clongene Biotech Co.Ltd. China

CE Approved
4

M/S                   Vishat

Diagnostics Pvt Ltd Mumbai
Antibody rapid test IgG/IgM

M/S Hangzhou All Test Biotech co Ltd China

CE approved
5 S.D. Biosensor Delhi Fluorescent     Rapid ANTIGEN Test

M/s S.D. Biosensor, korea

CE Approved
6

M/S               Trivitron Healthcare    Pvt       Ltd

,Chennai
Antibody test IgG/IgM CE approved M/s Autobio Diag Co Ltd, China
7

M/S               Trivitron Healthcare    Pvt       Ltd

,Chennai

Chemiluminescence Immuno Assay CLIA

CE approved
M/s Shenzhen New Industries Biomedical Engineering (SNIBE), China
8

M/S                  SNIBE

Diagnostics     (India), Gurgaon

Chemiluminescence Immuno Assay CLIA

CE approved
M/s Shenzhen New Industries Biomedical Engineering (SNIBE), China
9

M/S                   Vishat

Diagnostics Pvt Ltd Mumbai

ELISA

CE approved
M/S Zhenghou Human well Biocel Technology Ltd China
10

M/s    Sowar    Private Ltd

Delhi

Rapid       Antibody       test IgG/IgM

CE approved
M/S     Getein Biotech            Inc China
11 M/S     Immunoshop India Pvt Ltd Thane

Chemiluminescence Immuno Assay CLIA

CE approved
M/s Shenzhen New Industries Biomedical Engineering (SNIBE), China
12

M/S Athenese Dx Pvt Ltd

Chennai

Rapid       Antibody       test IgG/IgM

CE approved
M/s Beijing Genese Biotech Inc , China
13

M/S                  Bioline

Diagnostics , Delhi
Antibody test IgG/IgM CE approved

M/S    Hangzhou    All    Test Biotech co Ltd China

CE approved
14 M/S     Immunoshop India Pvt Ltd Thane Antibody test IgG/IgM CE approved M/s      Goldsite           Diagnostics Inc, China
15 Accurex          Biomedical Pvt Ltd, Thane Antibody test IgG/IgM CE approved M/S     Getein Biotech            Inc, China
16

Indelox             Global

Distribution, Pvt Ltd, Bangalore
Antibody test IgG/IgM CE approved

M/S       Dongguan        Bosh Biotechnology

China
17 M/S POCT Services Pvt Ltd Delhi Antibody test IgG/IgM CE approved M/S Zybo Inc China
18 M/S     Krishgen Biosystems Mumbai Antibody test IgG/IgM CE approved M/sWuhan       UNScience Biotechnology co Ltd, China
19

M/s                    Rapid

Diagnostics Pvt Ltd Delhi
Antibody test IgG/IgM CE approved

M/s Hangzhou Biotech Co Ltd

China
20 M/s PTS Diagnostics India Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Changsha Sinocare Inc China
21 M/s Gland Pharma Antibody test IgG/IgM CE approved M/S Shanghai Fosun Long March, China
22 M/s      Accrediated Consultant Pvt Ltd Antibody test IgG/IgM CE approved M/S     Hangzhou        All        Test Biotech co Ltd China
23 M/s      Accrediated Consultant Pvt Ltd Antibody test IgG/IgM CE approved M/S Humasis Co Ltd Korea
24 M/s Cosmic Scientific Chennai Antibody test IgG/IgM CE approved M/S     Getein Biotech            Inc, China
25 M/S     Agappe Diagnostics Ltd Antibody test IgG/IgM CE approved

M/s Hangzhou Biotech Co Ltd

China
26

M/S Trivitron

Healthcare Ltd

Antibody test

IgG/IgM CE approved

M/S Beijing Lepu

Medical Technology Co Ltd China
27

M/S Rafael Diagnostics,

Pune

Antibody test IgG/IgM CE

approved

M/S BMT

Diagnostics Israel
28 M/S Matrix Lab Chennai

CLIA

CE Approved

Auto- biodiagnostics Co

Ltd China
29 M/S Providence International Labs Antibody test IgG/IgM CE approved M/S Hangzhou Reality Tech Co Ltd
30 M/S Voxtur Bio Ltd Antibody test IgG/IgM Indigenous
31 M/S Vanguard Diag Pvt Ltd Antibody test IgG/IgM Indigenous
32 M/S S.D.Biosensor, Pvt Ltd

Antibody test IgG/IgM

Duo(Standard Q)
M/s S.D . Biosensor, Inc South Korea
33 M/S Weldon Biotech(I) Pvt.Ltd. iChrome FIA( Fluoracence ImmunoAssay) Covid-19 Ab M/s Boditech Med Inc. Korea
34 M/s HLL Antibody test IgG/IgM Indigenous
35 M/s Raymed Trading Group Pvt. Ltd.

Antibody test IgG/IgM

CE approved
M/S Beijing Lepu Medical Technology Co Ltd China
36 Hemogenomics Pvt. Ltd. Bangalore

Antibody test IgG/IgM

CE approved
M/S PCL Inc. South Korea
37 M/s Aracion Technology Pvt. Ltd

Antibody test IgG/IgM

CE approved
M/S Hecin Scientific Inc. China
38 M/s CPC Diagnostics Pvt. Ltd.

Anti SAR- COV-2 ELISA

IgA/ IgG
M/s Euroimmune AG Germany
39 M/s Bilcare Ltd. Pune

Antibody test IgG/IgM

CE approved
M/S     Getein Biotech Inc, China
40 M/s Bravo Pharmaceuticals Pvt. Ltd.

Antibody test IgG/IgM

CE approved
M/s Biosynex S.A France
41 M/s Harmony LifeSciences Pvt. Ltd.

Antibody test IgG/IgM

CE approved
M/s Humasis Co. Ltd. South Korea
42 M/s Inbios India, New Delhi

Antibody test IgG/IgM

CE approved
M/S     Getein Biotech Inc, China
43 M/s Imperial LifeSciences Pvt. Ltd

Antibody test IgG/IgM

CE approved
M/s NewScen Coast Biopharmaceutical Co. Ltd. China
44 M/s POCT Services Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Gen Body Inc. South Korea
45 M/s Trivitron Healthcare Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Innovita(Tang Shen) Biological Technology Co. Ltd. China
46 M/s Concept HealthCare Antibody test IgG/IgM CE approved

M/s Celtex Biotech(Suzhou) Co. Ltd.

China
47 M/s Bio Innovations Thane Antibody test IgG/IgM CE approved M/s Primer Design Ltd. U.K
48 M/s AR KAY Medicos Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Humasis Co. Ltd. South Korea
49 M/s Kin Diagnostics West Bengal FIA iChroma IgG/IgM CE approved M/s Boditech Med Inc. South Korea
50 M/S Aracion Technology Pvt LTd Antibody test IgG/IgM CE approved M/s Innovita(Tang Shen) Biological Technology Co. Ltd.China
51 M/S Meridian Medicare LTD Antibody test IgG/IgM CE approved M/s Gen Body Inc. South Korea
52 M/S SD Bio Sensor Healthcare Pvt Ltd Standard Q COVID-19 IgG/IgM Duo Indigenous
53 M/S Tara Medicos Pvt Ltd Jaipur Antibody test IgG/IgM CE approved M/S CELLEX INC,CHINA
54 M/s Med Source Ozone Biomedicals Pvt Ltd COVID-19 IgG/IgM Rapid Test Indigenous
55 Immunoscience India Pvt Ltd COVID-19 IgG/IgM Rapid Test Indigenous
56 M/s S.D Biosensor Healthcare Pvt. Ltd. Standard Q Covid-19 IgG/IgM Combo M/s S.D Biosensor Inc. Korea
57 M/s BioHouse Solutions Pvt. Ltd. Delhi COVID-19 IgG/IgM Rapid Test M/s Bio Medomics Inc. USA
58 M/s True Healthcare India Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Humasis Co. Ltd. South Korea
59 M/s Immunoshop India Pvt. Ltd. Antibody test IgG/IgM CE approved M/S Shenzhen Cifotrunic Technology Ltd. China
60 M/s Clini Experts Services Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Biocan Diagnostics Inc. Canada
61 M/s Inbios India, Delhi Antibody test IgG/IgM CE approved M/S CELLEX Biotech (Suzhou) Co. Ltd ,CHINA
62 M/S Synergy Scientific Services Pvt Ltd Antibody test IgG/IgM CE approved M/S Schenzhen Reagent Technology Co Ltd China
63 M/S Bioscience Sales Corp. Delhi Antibody test IgG/IgM CE approved M/S Shenzhan Watmind Medical Co. Ltd , China
64 M/s Gastro Lab India Pvt Ltd Antibody test IgG/IgM CE approved M/S Sche Bo Biotech AG, Germany
65 M/S Doctor Analytical Laboratories Pvt Ltd Antibody test IgG/IgM CE approved M/s Biocan Diagnostics Inc. Canada
66

M/S MDAAC

International Pvt Ltd

Antibody test IgG/IgM

CE approved
M/S Atlab Link(Beijing) Technology Co Ltd , China
67 M/S Kin Diagnostics Antibody test IgG/IgM CE approved M/S Sugentech Inc South Korea
68 M/s Alere Medical Pvt. Ltd.

PanBio Antibody test IgG/IgM

CE approved

M/s Abbott Rapid Diagnostics Germany Having Mfg. Site at Abon Biopharma(Hangzhou)

Co. Ltd. China
69 M/s Incarp Instruments Pvt. Ltd. Hyderabad

FIA IgG/IgM AntiBody Test

CE approved
M/s Boditech Med Inc. South Korea
70 M/s Nucleus 18 Turnkey Projects Pvt. Ltd. Telangana Antibody test IgG/IgM Australian EUA

M/s Innovita (Tangshan) Biological Technology Co. Ltd.

China
71 M/S Elder Projects Ltd Mumbai Antibody test IgG/IgM CE approved M/S Shanghai Outdo Biotech Co Ltd China
72 M/S KDH Biomedicals Pvt Ltd Mumbai Antibody test IgG/IgM CE approved M/s Dynamiker Biotechnology (Tianjin) Co Ltd China
73 M/S KDH Biomedicals Pvt Ltd Mumbai

ELISA IgG and ELISA
IgM/IgA

CE approved
M/s Dynamiker Biotechnology (Tianjin) Co Ltd China
74 Bio Dx Healthcare New Delhi Antibody test IgG/IgM CE approved M/S Zybio Inc, China
75 M/s Trivitron Healthcare Pvt LTD Antibody test IgG/IgM CE approved

M/s Shenzhen Lifotronic Technology Co. Ltd.

China
76 M/s Saffron Naturele Product Pvt. Ltd. U.P Antibody test IgG/IgM CE approved M/s Hangzhou Clongene Biotech Co. Ltd. China
77 M/s Bioplus Healthcare Pvt Ltd Bangalore Antibody test IgG/IgM CE approved M/s Cellex BioTech (Suzhou) Co. Ltd. China
78 M/s N.W Overseas, Haryana Antibody test IgG/IgM CE approved

M/s Beijing Lepu Medical Technology Co. Ltd.

China
79 M/s Premier Nutraceuticals Pvt. Ltd. Antibody test IgG/IgM CE approved M/s Shanghai Outdo Bio Tech Co. Ltd. China
80 M/s Genetix BioTech Asia Ltd.. Antibody test IgG/IgM M/s Sugentech Inc. South Korea
81 M/S Alpine Biomedicals Pvt Ltd Haryana Rapid Antibody test IgG/IgM Indigenous
82 S A Diagnostics Pvt Ltd Mumbai Antibody test IgG/IgM M/S Genrui Biotech Inc China
83 M/s Abbott Healthcare Pvt Ltd Chemiluminescent Microparticle Immunoassay With Architect System M/SAbbott Ireland Diag Div. Ireland
84 M/s Lab Care Diag, India Pvt Ltd Antibody test IgG/IgM Indigenous
85 M/S Nulife, Noida Antibody test IgG/IgM Indigenous
86 M/s Tulip Diagnostics Pvt Ltd Goa Coviscreen-Rapid Double Antigen test for detection of IgG/IgM Indigenous
87 M/s Roche Diagnostics India Pvt. Ltd. Delhi

ECLIA

Elecys Anti SARS COV2
M/s Roche Diagnostics GmbH, Germany
88 M/s Sidak LifeCare Pvt. Ltd. Antibody test IgG/IgM Indigenous
89 M/s S.D Biosensor HealthCare Pvt. Ltd. Standard Q COVID-19 IgG/IgM Combo Indigenous
90 M/s Diasorin Healthcare India Pvt. Ltd. CLIA M/s Diasorin S.P.A, Itlay
91 M/s Iris Hightech Pvt. Ltd. Delhi Antibody test IgG/IgM M/s Pharmact GmbH, Germany
92 M/s Mindray Medical India Pvt. Ltd. Mumbai CLIA M/s Shenzhen Mindray, China
93 M/s Ortho Clinical Diagnostics India Pvt. Ltd. Vitros Immunodiagnostic Total Reagent Pack M/s Ortho Clinical Diagnostics, USA
94 M/s DiaSys Diagnostics India Pvt. Ltd Antibody test IgG/IgM M/s Beining Lepu Medical Technology Co Ltd China
95 M/s Jetta Labs Antibody test IgG/IgM M/s Hanghzhou Test Sea Biotechnology China
96 M/s V.S Yarns Pvt. Ltd. Ludhiana Antibody test IgG/IgM M/s Accobiotech, Malaysia
97 M/s CliniExperts Services Pvt. Ltd Antibody test IgG/IgM M/s Europlaz Technologies, U.K
98 M/s Cadila Healthcare Ltd. ELISA Indigenous
99 M/s Deep Meditech Pvt. Ltd. Delhi Antibody test IgG/IgM M/s Autobio Diag Co Ltd, China


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