Product code LKQ— Microbiology
ABBOTT CMV-M EIA KIT
- Classification name
- Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code LKQ
FDA has cleared devices under product code LKQ between 1983 and 2010, filed by 16 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
- 2010
- 1997
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1983
Top applicants under product code LKQ
Recent clearances under product code LKQ
- K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL
- K933549 — VIDAS CMV IGM ASSAY
- K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA
- K914789 — ELISA CMV IGM
- K913080 — OPUS(R) ANTI CMV-M
- K900743 — CMV-IGM IFA TEST SYSTEM
- K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
- K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
- K872881 — ABBOTT CMV-M EIA KIT
- K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
- K871832 — CMV IGM MICROASSAY
- K863798 — FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
- K861363 — ENZYGNOST ANTI-CMV IGM TEST
- K860450 — THE CMV-IGM TEST
- K853889 — CORDIA CMV-M
- K854839 — CYTOMEGELISA M TEST KIT
- K831711 — CMV IGM TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.