ClearanceBrief
Panels › Microbiology › Product code LOM · Class 2

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Regulation 866.3172

1510(k)s in 12 months (1 all time)
0recalls in 12 months (34 all time)
0recalls that name a 510(k)
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Top companies in LOM

DateFirm and productCodeLinked 510(k)
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Open, Classified
LOMNone listed
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Open, Classified
LOMNone listed
Jun 13, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Open, Classified
LOMNone listed
Jan 19, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Open, Classified
LOMNone listed
Feb 17, 2023Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pedia
Open, Classified
LOMNone listed
Nov 1, 2018ORTHO-CLINICAL DIAGNOSTICS
VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals wh
Open, Classified
LOMNone listed
Nov 1, 2018ORTHO-CLINICAL DIAGNOSTICS
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old)
Open, Classified
LOMNone listed
May 4, 2018Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HBc IgM
Terminated
LOMNone listed
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
Terminated
LOMNone listed
Oct 21, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test fo
Terminated
LOMNone listed
Oct 21, 2014Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagn
Terminated
LOMNone listed
Dec 20, 2013Ortho-Clinical Diagnostics
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Terminated
LOMNone listed
Oct 21, 2013Bio-Rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Terminated
LOMNone listed
Apr 23, 2013Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surfac
Terminated
LOMNone listed
Mar 25, 2013Abbott Laboratories, Inc
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immu
Terminated
LOMNone listed
Sep 17, 2012Bio-Rad Laboratories
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatit
Terminated
LOMNone listed
Mar 22, 2011Diasorin Inc.
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoa
Terminated
LOMNone listed
May 20, 2010Bio-Rad Laboratories
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative
Terminated
LOMNone listed
Apr 15, 2009Abbott Laboratories
AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and
Terminated
LOMNone listed
Apr 15, 2009Abbott Laboratories
AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HB
Terminated
LOMNone listed
Jan 24, 2008Abbott Laboratories
Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Oct 31, 2007Bio-Rad Laboratories
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
Terminated
LOMNone listed
Jul 24, 2007Abbott Diagnostic International, Ltd.
ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
Terminated
LOMNone listed
Jul 24, 2007Abbott Diagnostic International, Ltd.
Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
Terminated
LOMNone listed
Jul 24, 2007Abbott Diagnostic International, Ltd.
ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.
Terminated
LOMNone listed
Jul 11, 2007Abbott Laboratories
AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Jul 11, 2007Abbott Laboratories
AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Jul 11, 2007Abbott Laboratories
AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Jul 11, 2007Abbott Laboratories
AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Apr 14, 2007Ortho-Clinical Diagnostics
VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests p
Terminated
LOMNone listed
Jan 6, 2006Ortho-Clinical Diagnostics
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of
Terminated
LOMNone listed
Sep 30, 2004Abbott Laboratories HPD/ADD/GPRD
Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
Dec 11, 2003Abbott Laboratories HPD/ADD/GPRD
Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed
May 9, 2003Abbott Laboratories HPD/ADD
Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Terminated
LOMNone listed

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