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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Markers for auto-immune diseases
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Autoimmune connective tissue diseases
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Autoimmune connective tissue diseases testing - other
Autoimmune connective tissue diseases testing - other
W0102100199
124 devices
Devices
Sharay Anti-Myositis Antibody Profile IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Sharay Anti-Myositis Antibody Profile IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
BioCLIA Autoimmune Reagent Kit, CENP-B
HOB Biotech Group Corp., Ltd.
·
,
CN
IVD General
CE/IVDD
ANTI-CARDIOLIPIN ANTIBODIES (ACA-IgG/IgM)
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
Sharay Anti-C1q IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
EliA RNA Pol III Well
Phadia AB
·
,
SE
Class B
FDA 510(k)
K202541
Active
Cleared 13 Sep 2021
CE/IVDR
+1
authorizations
Sharay Anti-α-Fodrin IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Human anti-salivary gland protein I antibody CLlA Kit (IgA)
Guangzhou Kangrun Biotech Co., Ltd.
·
,
CN
IVD General
CE/MDR
Sharay Anti-PCNA IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
Sharay Anti-Myositis Antibody Profile IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Rheumatology IgG Profile Kit
iCarbonX IntelliCore (Guangdong) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Sharay Anti-Ro52 IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
FIDIS Connective Profile
Biosynex
·
,
FR
IVD General
CE/IVDD
Sharay Anti-Myositis Antibody Profile IgG (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Human anti-salivary gland protein I antibody CLlA Kit (IgG)
Guangzhou Kangrun Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Human anti-parotid secretory protein antibody CLIA Kit (IgA)
Guangzhou Kangrun Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
FIDIS Connective Profile
Biosynex
·
,
FR
IVD General
CE/IVDD
MosaiQ® AiPlex CTDplus
AliveDx Suisse SA
·
,
CH
Class B
CE/IVDR
ANTI-ANNEXIN V IgG/IgM (ANX)
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
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