FDA.reportPublic FDA data

Hepatitis B virus surface total antibody IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus surface in a clinical specimen.
GUDID devices
15
Last updated
2020-04-20 21:34:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10758750001972VITROSORTHO CLINICAL DIAGNOSTICS68020932020-04-08
08056771103459LIAISON® XL MUREX Control Anti-HBsDIASORIN SPA3182212020-02-27
08056771103466LIAISON® XL MUREX Anti-HBs VerifiersDIASORIN SPA3182232020-02-27
00380740151300AlinityAbbott Ireland Diagnostics07P88102019-09-10
04015630910908Elecsys PreciControl Anti-HBsRoche Diagnostics GmbH118763171602014-09-10
04015630999286Elecsys Anti-HBs CalCheckRoche Diagnostics GmbH049853541602014-09-01
07613336159798PreciControl Anti-HBsRoche Diagnostics GmbH118763171602018-08-23
07613336159804Anti-HBs CalCheckRoche Diagnostics GmbH049853541602018-08-30
00630414471860ADVIA Centaur® Systems aHBs QCSiemens Healthcare Diagnostics Inc.103090202014-09-24
00630414551777ADVIA Centaur® Systems aHBs2 QCSiemens Healthcare Diagnostics Inc.102830882014-09-24
00630414555300ADVIA Centaur® Systems aHBs2 MCMSiemens Healthcare Diagnostics Inc.102859622014-09-24
00630414597843Atellica™ IM aHBs2 QCSiemens Healthcare Diagnostics Inc.109954542018-10-16
00630414600512Atellica™ IM aHBs2 MCMSiemens Healthcare Diagnostics Inc.109956672018-10-25
00380740001506ARCHITECTAbbott Ireland Diagnostics1L82-122014-11-18
00380740105419ARCHITECTAbbott Ireland Diagnostics1L82-132017-04-28