Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Immunochemistry (immunology)
/
Immunochemistry controls/standards/calibrators
/
Controls - immunochemistry
/
Specific protein controls
Specific protein controls
W0102152003
285 devices
TIgE Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
MxA/CRP Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Immunotyping Control
Helena Biosciences Europe
·
,
United Kingdom
Class C
CE/IVDR
Alpha1-microglobulin control L
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
OC-FCa Control LV2
Eiken Chemical Co., Ltd.
·
,
Japan
Class B
CE/IVDR
B·R·A·H·M·S anti-Tgn/-TPOn KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
S100-β Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Aaca Positive Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Quality Control (D-Dimer)
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
FDA 510(k)
×2
K111938
Active
Cleared 14 Feb 2012
CE/IVDD
+1
authorizations
SAA Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Serum Amyloid A Protein Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
PCT Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Quantia Ferritin/ Myoglobin/IgE Control
Biokit, S.A.
·
,
Spain
Class C
CE/IVDR
Multiparametric controls M
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Pepsinogen-I/Pepsinogen-II Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
ANA-Ce POSITIVE CONTROL
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
GCAL®NEPH Controls
Gentian AS
·
,
Norway
Class B
CE/IVDR
Alpha1-microglobulin control L
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Beta-2 Microglobulin Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Previous
Next