STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY

EMDN W0102152211

Parent W01021522 STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY

Registry term list. Not a clinical opinion. 87 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM)	00630414608822	Siemens Healthcare Diagnostics Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ADVIA Centaur aTPOII Quality Control (aTPOII QC)	00630414608587	Siemens Healthcare Diagnostics Products Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ADVIA Centaur Calibrator 1	00630414587899	Siemens Healthcare Diagnostics Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Alinity	00380740150570	Abbott Ireland, Diagnostics Division	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Alinity	00380740150594	Abbott Ireland, Diagnostics Division	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anti-SS-B IgG CLIA Microparticles	06942359512626	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anti-Tg Calibrators	06903053100427	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anti-Tg Calibrators	06903053100434	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva	08430793040181	Inova Diagnostics. Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva	08430793040570	Inova Diagnostics. Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva® APS IgA Calibrators	08430793040839	Inova Diagnostics. Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva® APS IgG Calibrators	08430793040761	Inova Diagnostics. Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva® APS IgM Calibrators	08430793040907	Inova Diagnostics. Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Aptiva Celiac Disease IgG Calibrators	08430793040518	Inova Diagnostics. Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Atellica IM aTPOII Master Curve Material (aTPOII MCM)	00630414608778	Siemens Healthcare Diagnostics Inc.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Atellica IM aTPOII Quality Control (aTPOII QC)	00630414608891	Siemens Healthcare Diagnostics Products Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo AMA-M2 IgG Calibrators	06942359513449	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo ANA IgG Calibrators	06975577178732	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-CCP IgG Calibrators	06942359505369	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-CL Calibrators	06975577178749	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-CL IgA Calibrators	06975577178770	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-CL IgG Calibrators	06975577178756	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-CL IgM Calibrators	06975577178763	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-dsDNA IgG Calibrators	06975577178725	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-GBM IgG Calibrators	06942359513357	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-gp210 IgG Calibrators	06942359513531	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-MPO IgG Calibrators	06942359513265	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-nRNP/Sm IgG Calibrators	06942359512992	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-PR3 IgG Calibrators	06942359513173	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-Ribosomal P IgG Calibrators	06942359513081	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-Ro-52 IgG Calibrators	06942359512541	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-Scl-70 IgG Calibrators	06942359512725	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-Sm IgG Calibrators	06942359512909	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-sp100 IgG Calibrators	06942359513623	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-SS-A/Ro IgG Calibrators	06942359512459	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-SS-B IgG Calibrators	06942359512633	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-TPO Calibrators	06975577177384	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-β2-GP1 Calibrators	06975577178688	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-β2-GP1 IgA Calibrators	06975577178695	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-β2-GP1 IgG Calibrators	06975577178701	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo Anti-β2-GP1 IgM Calibrators	06975577178718	Autobio Diagnostics Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo RF Calibrators	06942359512091	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo RF IgA Calibrators	06942359512367	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo RF IgG Calibrators	06942359512275	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
AutoLumo RF IgM Calibrators	06942359512183	Autobio Diagnostics Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune Standard, AGA IgA	08058945155431	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune Standard, AGA IgG	08058945155479	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune Standard, AMA IgG	08058945155592	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune Standard, anti-b2-GPI IgG	08058945155639	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Evo Autoimmune Standard, anti-b2-GPI IgM	08058945155677	ABD SRL	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED