Atlas FDA

LFZ

58 FDA 510(k) clearances · Product code

174 daysmedian time to decision
417 days90th percentile
58clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3175
Medical specialty
Microbiology
Adverse events (MAUDE)
2017: 13 · 2021: 23 · 2023: 36 · 2024: 34 · 2025: 54 · 2026: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Architect CMV IgG (K220949)Abbott Laboratories2022-10-27
Elecsys CMV IgG (K220911)Roche Diagnostics2022-10-12
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213)Siemens Healthcare Diagnostics, Inc.2018-07-30
Elecsys CMV IgM (K163569)Roche Diagnostics2017-03-17
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (K162969)DiaSorin, Inc.2017-01-06
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (K142133)Roche Diagnostics2014-10-24
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605)Roche Diagnostics2014-02-28
DIASORIN LIAISON CMV IGM/IGG (K040290)Diasorin S.P.A2005-06-01
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
SERAQUEST CMV IGM (K982485)Quest Intl., Inc.1999-01-13
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K984139)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983803)Zeus Scientific, Inc.1998-12-14
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY (K982027)DiaSorin, Inc.1998-11-25
DIAMEDIX IS-CMV IGG TEST SYSTEM (K981163)Diamedix Corp.1998-09-21
QUANTA LITE CMV IGG ELISA (K971335)Inova Diagnostics, Inc.1997-12-01
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) (K954301)Abbott Laboratories1997-03-24
HEMAGEN CMV IGG KIT (K944438)Hemagen Diagnostics, Inc.1997-02-20
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 (K960434)Incstar Corp.1996-10-17
OPUS CMV TEST SYSTEM-MODIFICATION (K963084)Behring Diagnostics, Inc.1996-10-09
AXSYM CMV IGG ANTIBODY ASSAY (K953943)Abbott Laboratories1996-09-20
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (K955361)Incstar Corp.1996-07-22
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY (K955360)Incstar Corp.1996-07-22
IMMULITE CMV IGG (K950672)Diagnostic Products Corp.1996-06-17
SERAQUEST CMV IGG (K954191)Quest Intl., Inc.1996-02-23
OPUS CMV-G (K933389)Pb Diagnostic Systems, Inc.1994-06-28
BARTELS CYTOMEGALOVIRUS IGG EIA (K922582)Baxter Diagnostics, Inc.1993-04-08
CMV ELISA TEST SYSTEM (K924096)Zeus Scientific, Inc.1993-04-02
VIDAS CMV IGG ASSAY (K920661)Vitek Systems, Inc.1993-02-12
PHARMACIA CMV IGM ELISA (K921011)Pharmacia Diagnostics, Inc.1992-07-27
CAPTIA CMV-TA (K915479)Mercia Diagnostics , Ltd.1992-05-04
ENZYGNOST(R) ANTI-CMV IGG (K913910)Behring Diagnostics, Inc.1992-04-28
ENZYGNOST(R) ANTI-CMV/IGM (K913693)Behring Diagnostics, Inc.1992-02-27
CMV IGG ELISA TEST (K915892)Gull Laboratories, Inc.1992-02-14
ENZYGNOST ANTI-CMV/IGG + IGM (K901485)Behring Diagnostics, Inc.1991-05-20
CYTOMEGALOVIRUS (CMV) ELISA (K904456)Virotech, Inc.1991-04-03
ORTHO CMV-M ANTIBODY ELISA TEST (K905077)Ortho Diagnostic Systems, Inc.1990-12-17
ORTHO CMV-G ANTIBODY ELISA TEST (K905078)Ortho Diagnostic Systems, Inc.1990-12-17
CMV IGM ELISA TEST (K903807)Gull Laboratories, Inc.1990-12-17
IMX CMV IGM ANTIBODY ASSAY (K900473)Abbott Laboratories1990-07-27
IMX CMV IGG ANTIBODY ASSAY (K900474)Abbott Laboratories1990-07-27
CMV IGG ELISA TEST (K900796)Gull Laboratories, Inc.1990-05-02
CAPTIA(R) CMV-M (K896295)Mercia Diagnostics , Ltd.1990-03-06
CAPTIA(R) CMV-G (K896194)Mercia Diagnostics , Ltd.1990-03-06
CMV IGM ELISA TEST SYSTEM (K896355)Zeus Scientific, Inc.1990-02-27
DETECTADOT TM SYSTEM 2000 CMV IGM TEST (K893230)Gull Laboratories, Inc.1989-12-18
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT (K891393)Orgenics, Ltd.1989-06-23
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM (K890610)Organon Teknika Corp.1989-06-23
CMV ELISA TEST SYSTEM (K891081)Zeus Scientific, Inc.1989-06-02
CMV-CUBE(TM) (K884842)Difco Laboratories, Inc.1989-04-11
MODIFIED DDI SEROCARD CMV IGG TEST KIT (K884248)Disease Detection International, Inc.1989-04-10
UBI MAGIWEL CMV IGG QUANTITATIVE (K883399)United Biotech, Inc.1989-03-27
CYTOMEGALOVIRUS IGG EIA KIT (K880433)De Ferris Laboratories, Inc.1989-03-27
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT (K875361)Disease Detection International, Inc.1988-05-13
ENZYGNOST + ANTI-CMV IGG TEST (K852478)Behring Diagnostics, Inc.1985-09-16
YBBOTT CMV TOTAL AB EIA (K832221)Abbott Laboratories1983-10-27
CMV RQ BIO-ENZABEAD KIT (K831343)Litton Bionetics1983-08-08
CYTOMEGELISA STAT (K830615)M.A. Bioproducts1983-05-09
CORDIA CMV (K823123)Cordis Corp.1982-12-28

Track LFZ automatically

Every clearance here is in the API, with alerts when new ones post.