LOM

Product Code: LOM


Products Classified as LOM

3598Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

Total Product Life Cycle (TPLC) Devices

3598Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

Pre-market Approvals for LOM

P010053IMMULITE 2000 XPI ANTI-HBC IMGSiemens Healthcare Diagnostics Products, LTD
P010051IMMULITE 2000 XPI ANTI-HBCSiemens Healthcare Diagnostics Products, LTD
P010050IMMULITE 2000 XPI HBSAGSiemens Healthcare Diagnostics Products, LTD
P010052IMMULITE 2000 XPI ANTI-HBSSiemens Healthcare Diagnostics Products, LTD
P990045ETI-AB-COREK PLUSDIASORIN, INC.
P990044DIASORIN ETI-CORE-IGMK PLUSDIASORIN, INC.
P030029ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORSSIEMENS HEALTHCARE DIAGNOSTICS
P990041DIASORIN ETI-AB-EBK PLUS ASSAYDIASORIN, INC.
P060034BIO RAD MONOLISA ANTI-HBC IGM EIABio-Rad Laboratories, Inc.
P130015Elecsys HBeAg and PreciControl HBeAgROCHE DIAGNOSTICS OPERATIONS INC
P050051Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs ControlsABBOTT LABORATORIES INC
P080023Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc ControlsAbbott Laboratories
P030024VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and CalibratorORTHO-CLINICAL DIAGNOSTICS
P000014VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
P000044VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory KitOrtho-Clinical Diagnostics, Inc.

Global Unique Device Identification Database

00380740115388Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740115371Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740115364Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740105433Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740105426Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740105419Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740105402Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011154Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011147Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011130Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011123Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011116Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740011109Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740007805Test, hepatitis b (b core, be antigen, be antibody, b core igm)
00380740007799Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Maude Adverse Events

ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-03-20
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-03-12
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-03-12
ATELLICA IM ANTI-HBS2 (AHBS2) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-03-09
ARCHITECT ANTI-HBC IIABBOTT GMBH2020-03-05
HBSAG G2 ELECSYS COBAS E 100ROCHE DIAGNOSTICS2020-03-05
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-03-02
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-28
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-26
HBSAG G2 ELECSYS E2G 300 V2ROCHE DIAGNOSTICS2020-02-25
ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-24
ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-24
ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-24
ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-24
ARCHITECT ANTI-HBC IGMABBOTT GMBH2020-02-19
ARCHITECT ANTI-HBC IIABBOTT GMBH2020-02-19
ARCHITECT HBSAG QUALITATIVE CONFIRMATORYABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-18
ELECSYS HBSAG CONFIRMATORY TESTROCHE DIAGNOSTICS2020-02-18
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-17
ELECSYS HBSAG CONFIRMATORY TESTROCHE DIAGNOSTICS2020-02-14
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-06
ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-06
ARCHITECT ANTI-HBC IIABBOTT GMBH2020-02-05
ALINITY I ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-04
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-04
ELECSYS ANTI-HBS IMMUNOASSAYROCHE DIAGNOSTICS2020-02-04
ALINITY I ANTI-HBCABBOTT GMBH2020-01-31
ALINITY I HBSAG QUALITATIVE II CONFIRMATORYABBOTT IRELAND DIAGNOSTICS DIVISION2020-01-29
ALINITY I HBSAG QUALITATIVE II CONFIRMATORYABBOTT IRELAND DIAGNOSTICS DIVISION2020-01-29
HBSAG G2 ELECSYS COBAS E 100ROCHE DIAGNOSTICS2020-01-29
ARCHITECT ANTI-HBC IIABBOTT GMBH2020-01-20
ELECSYS HBSAG CONFIRMATORY TESTROCHE DIAGNOSTICS2020-01-17
ELECSYS ANTI-HBCROCHE DIAGNOSTICS2020-01-13
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
ALINITY S ANTI-HBCABBOTT GMBH2020-01-09
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2020-01-09
ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-08
ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-01-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-06
ALINITY I ANTI-HBCABBOTT GMBH2020-01-03
ARCHITECT ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2019-12-27
ALINITY I ANTI-HBSABBOTT IRELAND DIAGNOSTICS DIVISION2019-12-13

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