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)
Top companies in LOM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. Open, Classified |
LOM | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. Open, Classified |
LOM | None listed |
| Jun 13, 2024 | Ortho-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 |
LOM | None listed |
| Jan 19, 2024 | Ortho-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 |
LOM | None listed |
| Feb 17, 2023 | Siemens 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 |
LOM | None listed |
| Nov 1, 2018 | ORTHO-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 |
LOM | None listed |
| Nov 1, 2018 | ORTHO-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 |
LOM | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur HBc IgM Terminated |
LOM | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi Anti HBc Terminated |
LOM | None listed |
| Oct 21, 2014 | Siemens 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 |
LOM | None listed |
| Oct 21, 2014 | Siemens 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 |
LOM | None listed |
| Dec 20, 2013 | Ortho-Clinical Diagnostics VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs Terminated |
LOM | None listed |
| Oct 21, 2013 | Bio-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 |
LOM | None listed |
| Apr 23, 2013 | Ortho-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 |
LOM | None listed |
| Mar 25, 2013 | Abbott 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 |
LOM | None listed |
| Sep 17, 2012 | Bio-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 |
LOM | None listed |
| Mar 22, 2011 | Diasorin 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 |
LOM | None listed |
| May 20, 2010 | Bio-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 |
LOM | None listed |
| Apr 15, 2009 | Abbott 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 |
LOM | None listed |
| Apr 15, 2009 | Abbott 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 |
LOM | None listed |
| Jan 24, 2008 | Abbott 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 |
LOM | None listed |
| Oct 31, 2007 | Bio-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 |
LOM | None listed |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Apr 14, 2007 | Ortho-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 |
LOM | None listed |
| Jan 6, 2006 | Ortho-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 |
LOM | None listed |
| Sep 30, 2004 | Abbott 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 |
LOM | None listed |
| Dec 11, 2003 | Abbott 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 |
LOM | None listed |
| May 9, 2003 | Abbott Laboratories HPD/ADD Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
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