Panels › Microbiology › Product code LFX · Class 2
Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation 866.3510
1510(k)s in 12 months (94 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
Top companies in LFX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | bioMerieux, Inc. VIDAS RUB IgG (RBG), REF 30226 Open, Classified |
LFX | None listed |
| Aug 24, 2016 | Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Un Terminated |
LFX | K012077 |
| Aug 24, 2016 | Siemens Healthcare Diagnostics, Inc. SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD -- Terminated |
LFX | K012077 |
| Nov 17, 2011 | Meridian Bioscience Inc EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4- Terminated |
LFX | K953362 |
| May 19, 2011 | Bio-Rad Laboratories Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***"
The EVOLIS Assay Protocol Files (APF) Software contains assay-specific Terminated |
LFX | K092353 K961053 |
| Mar 11, 2011 | BioCheck Inc Rubella IgG ELISA kit ;
Rubella IgM ELISA kit
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LFX | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000 and IMMULITE 2500
IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 Terminated |
LFX | None listed |
| Mar 10, 2010 | Siemens Healthcare Diagnostics Inc. IMMULITE 2000 and IMMULITE 2500
IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150 Terminated |
LFX | K033234 K970227 |
| Mar 2, 2010 | Diasorin Inc. DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28. Terminated |
LFX | K960367 |
| Mar 2, 2010 | Bio-Rad Laboratories Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Labor Terminated |
LFX | K961053 |
| Sep 16, 2008 | Abbott Laboratories AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20
The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitativ Terminated |
LFX | K954045 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFX | K954318 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFX | K954045 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFX | K931059 |
| Jul 30, 2003 | Zeus Scientific Inc Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigm Terminated |
LFX | K984180 |
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