Panels › Microbiology › Product code LFZ · Class 2
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation 866.3175
0510(k)s in 12 months (58 all time)
1recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in LFZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2022 | K220949 | Architect CMV IgG Abbott Laboratories | LFZ |
| Oct 12, 2022 | K220911 | Elecsys CMV IgG Roche Diagnostics | LFZ |
| Jul 30, 2018 | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control Siemens Healthcare Diagnostics, Inc. | LFZ |
| Mar 17, 2017 | K163569 | Elecsys CMV IgM Roche Diagnostics | LFZ |
| Jan 6, 2017 | K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set DiaSorin, Inc. | LFZ |
| Oct 24, 2014 | K142133 | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics | LFZ |
| Feb 28, 2014 | K131605 | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY Roche Diagnostics | LFZ |
| Jun 1, 2005 | K040290 | DIASORIN LIAISON CMV IGM/IGG Diasorin S.P.A | LFZ |
| Dec 16, 1999 | K993952 | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 Diagnostic Products Corp. | LFZ |
| Jan 13, 1999 | K982485 | SERAQUEST CMV IGM Quest Intl., Inc. | LFZ |
| Jan 11, 1999 | K984139 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LFZ |
| Dec 14, 1998 | K983803 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LFZ |
| Nov 25, 1998 | K982027 | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY DiaSorin, Inc. | LFZ |
| Sep 21, 1998 | K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM Diamedix Corp. | LFZ |
| Dec 1, 1997 | K971335 | QUANTA LITE CMV IGG ELISA Inova Diagnostics, Inc. | LFZ |
| Mar 24, 1997 | K954301 | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) Abbott Laboratories | LFZ |
| Feb 20, 1997 | K944438 | HEMAGEN CMV IGG KIT Hemagen Diagnostics, Inc. | LFZ |
| Oct 17, 1996 | K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 Incstar Corp. | LFZ |
| Oct 9, 1996 | K963084 | OPUS CMV TEST SYSTEM-MODIFICATION Behring Diagnostics, Inc. | LFZ |
| Sep 20, 1996 | K953943 | AXSYM CMV IGG ANTIBODY ASSAY Abbott Laboratories | LFZ |
| Jul 22, 1996 | K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY Incstar Corp. | LFZ |
| Jul 22, 1996 | K955360 | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY Incstar Corp. | LFZ |
| Jun 17, 1996 | K950672 | IMMULITE CMV IGG Diagnostic Products Corp. | LFZ |
| Feb 23, 1996 | K954191 | SERAQUEST CMV IGG Quest Intl., Inc. | LFZ |
| Jun 28, 1994 | K933389 | OPUS CMV-G Pb Diagnostic Systems, Inc. | LFZ |
| Apr 8, 1993 | K922582 | BARTELS CYTOMEGALOVIRUS IGG EIA Baxter Diagnostics, Inc. | LFZ |
| Apr 2, 1993 | K924096 | CMV ELISA TEST SYSTEM Zeus Scientific, Inc. | LFZ |
| Feb 12, 1993 | K920661 | VIDAS CMV IGG ASSAY Vitek Systems, Inc. | LFZ |
| Jul 27, 1992 | K921011 | PHARMACIA CMV IGM ELISA Pharmacia Diagnostics, Inc. | LFZ |
| May 4, 1992 | K915479 | CAPTIA CMV-TA Mercia Diagnostics , Ltd., GB | LFZ |
| Apr 28, 1992 | K913910 | ENZYGNOST(R) ANTI-CMV IGG Behring Diagnostics, Inc. | LFZ |
| Feb 27, 1992 | K913693 | ENZYGNOST(R) ANTI-CMV/IGM Behring Diagnostics, Inc. | LFZ |
| Feb 14, 1992 | K915892 | CMV IGG ELISA TEST Gull Laboratories, Inc. | LFZ |
| May 20, 1991 | K901485 | ENZYGNOST ANTI-CMV/IGG + IGM Behring Diagnostics, Inc. | LFZ |
| Apr 3, 1991 | K904456 | CYTOMEGALOVIRUS (CMV) ELISA Virotech, Inc. | LFZ |
| Dec 17, 1990 | K905078 | ORTHO CMV-G ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFZ |
| Dec 17, 1990 | K905077 | ORTHO CMV-M ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFZ |
| Dec 17, 1990 | K903807 | CMV IGM ELISA TEST Gull Laboratories, Inc. | LFZ |
| Jul 27, 1990 | K900474 | IMX CMV IGG ANTIBODY ASSAY Abbott Laboratories | LFZ |
| Jul 27, 1990 | K900473 | IMX CMV IGM ANTIBODY ASSAY Abbott Laboratories | LFZ |
| May 2, 1990 | K900796 | CMV IGG ELISA TEST Gull Laboratories, Inc. | LFZ |
| Mar 6, 1990 | K896295 | CAPTIA(R) CMV-M Mercia Diagnostics , Ltd., GB | LFZ |
| Mar 6, 1990 | K896194 | CAPTIA(R) CMV-G Mercia Diagnostics , Ltd., GB | LFZ |
| Feb 27, 1990 | K896355 | CMV IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LFZ |
| Dec 18, 1989 | K893230 | DETECTADOT TM SYSTEM 2000 CMV IGM TEST Gull Laboratories, Inc. | LFZ |
| Jun 23, 1989 | K891393 | ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT Orgenics, Ltd. | LFZ |
| Jun 23, 1989 | K890610 | VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM Organon Teknika Corp. | LFZ |
| Jun 2, 1989 | K891081 | CMV ELISA TEST SYSTEM Zeus Scientific, Inc. | LFZ |
| Apr 11, 1989 | K884842 | CMV-CUBE(TM) Difco Laboratories, Inc. | LFZ |
| Apr 10, 1989 | K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT Disease Detection International, Inc. | LFZ |
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