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Standards and calibrators immunochemistry
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Standards and calibrators for autoimmunity
Standards and calibrators for autoimmunity
W0102152211
93 devices
Devices
Evo Autoimmune Standard, anti-b2-GPI IgM
Abd SRL
·
,
IT
Class A
CE/IVDR
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
AutoLumo Anti-GBM IgG Calibrators
Autobio Diagnostics Co., Ltd.
·
,
CN
Class B
CE/IVDR
AutoLumo Anti-Ro-52 IgG Calibrators
Autobio Diagnostics Co., Ltd.
·
,
CN
Class B
CE/IVDR
Aptiva® CTD Essential Calibrators
Inova Diagnostics, Inc.
·
,
US
Class B
FDA 510(k)
K243979
Active
Cleared 6 Feb 2026
CE/IVDR
+1
authorizations
Aptiva® APS IgM Calibrators
Inova Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Human anti-parotid secretory protein antibody CLIA Kit (IgM)
Guangzhou Kangrun Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Aptiva Celiac Disease IgA Calibrators
Inova Diagnostics, Inc.
·
,
US
Class B
CE/IVDD
CE/IVDR
+1
authorizations
Evo Autoimmune Standard, anti-b2-GPI IgG
Abd SRL
·
,
IT
Class A
CE/IVDR
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
AutoLumo Anti-CCP IgG Calibrators
Autobio Diagnostics Co., Ltd.
·
,
CN
Class B
CE/IVDR
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Rheumatoid Factor Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
Aptiva® APS IgG Calibrators
Inova Diagnostics, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
AutoLumo Anti-CL IgA Calibrators
Autobio Diagnostics Co., Ltd.
·
,
CN
Class C
CE/IVDR
AutoLumo Anti-β2-GP1 IgM Calibrators
Autobio Diagnostics Co., Ltd.
·
,
CN
Class C
CE/IVDR
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
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