Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Infectious diseases
/
Parasitology (infect. immunology/nat)
/
Miscellaneous parasitology immunoassay
Miscellaneous parasitology immunoassay
W01050502
200 devices
Subcategories
11
W0105050201
Entamoeba histolytica
20
devices
W0105050202
Chagas
13
devices
W0105050203
Distomatosis
3
devices
W0105050204
Echinococcus
9
devices
W0105050205
Leishmania
15
devices
W0105050206
Schistosoma
3
devices
W0105050207
Cryptosporidium
14
devices
W0105050208
Giardia lamblia
23
devices
W0105050209
Plasmodium (malaria)
70
devices
W0105050210
Trichomonas
7
devices
W0105050299
Parasitology - other
23
devices
Devices
Cor
Becton, Dickinson and Company
·
,
United States
Class A
FDA 510(k)
K250358
Active
Cleared 31 Oct 2025
CE/IVDR
+1
authorizations
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
Accu-Tell® Chagas Strip (Whole Blood +2 more)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Rapid Test Cassette (Whole Blood +2 more)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Rapid Test
Beijing Jinwofu Bioengineering Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Chagas Cassette (Whole Blood +2 more)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Rapid Test Cassette (Serum/Plasma)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Combo Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas Ab Rapid Test Cassette (Whole Blood +2 more)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi
Genes 2Me Private Limited
·
,
India
IVD General
CE/IVDD
MAGLUMI Chagas (CLIA)
Shenzhen New Industries Biomedical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Chagas (Trypanosoma cruzi) IgG ELISA
Ibl International GmbH
·
,
Germany
IVD General
CE/IVDD
Chagas Ab Rapid Test Cassette (Serum/Plasma)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Chagas IgG/IgM Rapid Test
Hangzhou Immuno Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Schistosomiasis Real Time PCR Kit
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Fasciola hepatica IgG ELISA
Bordier Affinity Products SA
·
,
Switzerland
IVD General
CE/IVDD
GUDID
on market
HYDATIDOSIS ELISA IgG
Vircell, S.L
·
,
Spain
IVD General
CE/IVDD
Echinococcus multilocularis (Em18) IgG ELISA
Bordier Affinity Products SA
·
,
Switzerland
IVD General
CE/IVDD
GUDID
on market
Echinococcus granulosus IgG ELISA
Bordier Affinity Products SA
·
,
Switzerland
Class B
CE/IVDD
CE/IVDR
+1
authorizations
Previous
Next