Product code LFZ— Microbiology
CMV ELISA TEST SYSTEM
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code LFZ
FDA has cleared devices under product code LFZ between 1982 and 2022, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2018
- 2017
- 2014
- 2005
- 1999
- 1998
- 1997
- 1996
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
Top applicants under product code LFZ
Recent clearances under product code LFZ
- K220949 — Architect CMV IgG
- K220911 — Elecsys CMV IgG
- K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
- K163569 — Elecsys CMV IgM
- K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
- K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
- K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
- K040290 — DIASORIN LIAISON CMV IGM/IGG
- K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
- K982485 — SERAQUEST CMV IGM
- K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983803 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K982027 — MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
- K981163 — DIAMEDIX IS-CMV IGG TEST SYSTEM
- K971335 — QUANTA LITE CMV IGG ELISA
- K954301 — ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
- K944438 — HEMAGEN CMV IGG KIT
- K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
- K963084 — OPUS CMV TEST SYSTEM-MODIFICATION
- K953943 — AXSYM CMV IGG ANTIBODY ASSAY
- K955360 — INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
- K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
- K950672 — IMMULITE CMV IGG
- K954191 — SERAQUEST CMV IGG
- K933389 — OPUS CMV-G
- K922582 — BARTELS CYTOMEGALOVIRUS IGG EIA
- K924096 — CMV ELISA TEST SYSTEM
- K920661 — VIDAS CMV IGG ASSAY
- K921011 — PHARMACIA CMV IGM ELISA
- K915479 — CAPTIA CMV-TA
- K913910 — ENZYGNOST(R) ANTI-CMV IGG
- K913693 — ENZYGNOST(R) ANTI-CMV/IGM
- K915892 — CMV IGG ELISA TEST
- K901485 — ENZYGNOST ANTI-CMV/IGG + IGM
- K904456 — CYTOMEGALOVIRUS (CMV) ELISA
- K903807 — CMV IGM ELISA TEST
- K905077 — ORTHO CMV-M ANTIBODY ELISA TEST
- K905078 — ORTHO CMV-G ANTIBODY ELISA TEST
- K900473 — IMX CMV IGM ANTIBODY ASSAY
- K900474 — IMX CMV IGG ANTIBODY ASSAY
- K900796 — CMV IGG ELISA TEST
- K896194 — CAPTIA(R) CMV-G
- K896295 — CAPTIA(R) CMV-M
- K896355 — CMV IGM ELISA TEST SYSTEM
- K893230 — DETECTADOT TM SYSTEM 2000 CMV IGM TEST
- K890610 — VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
- K891393 — ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
- K891081 — CMV ELISA TEST SYSTEM
- K884842 — CMV-CUBE(TM)
- K884248 — MODIFIED DDI SEROCARD CMV IGG TEST KIT
- K880433 — CYTOMEGALOVIRUS IGG EIA KIT
- K883399 — UBI MAGIWEL CMV IGG QUANTITATIVE
- K875361 — SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
- K852478 — ENZYGNOST + ANTI-CMV IGG TEST
- K832221 — YBBOTT CMV TOTAL AB EIA
- K831343 — CMV RQ BIO-ENZABEAD KIT
- K830615 — CYTOMEGELISA STAT
- K823123 — CORDIA CMV
Data sourced from openFDA. This site is unofficial and independent of the FDA.