Panels › Microbiology › Product code LOL · Class 2
Hepatitis A Test (Antibody And Igm Antibody)
Regulation 866.3310
2510(k)s in 12 months (26 all time)
0recalls in 12 months (12 all time)
7recalls that name a 510(k)
Top companies in LOL
| Company | 510(k)s | Recalls |
|---|---|---|
| DiaSorin, Inc. | 8 | 1 |
| Abbott Laboratories | 3 | 3 |
| Bio-Rad Laboratories | 4 | 0 |
| Roche Diagnostics | 3 | 1 |
| Siemens Healthcare Diagnostics, Inc. | 3 | 0 |
| Abbott Gmbh & Co. KG | 0 | 2 |
| Abbott Health Products, Inc. | 0 | 2 |
| Beckman Coulter, Inc. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Abbott Diagnostics International, Ltd. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2020 | Abbott Gmbh & Co. KG ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. Terminated |
LOL | K113704 |
| Nov 26, 2019 | Abbott Gmbh & Co. KG ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Terminated |
LOL | K113704 |
| Oct 28, 2019 | Roche Diagnostics Operations, Inc. Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma
Catalog number: 07026773190 Terminated |
LOL | K093955 |
| Dec 17, 2018 | Roche Diagnostics Corporation Anti-HAV IgM test System, Material No. 11820591160
Product Usage:
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (ant Terminated |
LOL | K093955 |
| Jun 6, 2011 | Abbott Laboratories ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric seru Terminated |
LOL | K063329 |
| May 19, 2010 | Abbott Diagnostics International, Ltd. ARCHITECT HAVAB-M Reagent
A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and Terminated |
LOL | K063329 |
| May 6, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591. Terminated |
LOL | K971418 |
| Jul 11, 2007 | Abbott Laboratories AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOL | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOL | None listed |
| Apr 27, 2005 | Diasorin Inc. DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Terminated |
LOL | None listed |
| Mar 29, 2005 | Abbott Health Products, Inc. IMx HAVAB Controls In Vitro Test Terminated |
LOL | None listed |
| Nov 20, 2004 | Abbott Health Products, Inc. IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservati Terminated |
LOL | None listed |
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