Product code MJH— Microbiology
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- Classification name
- Legionella, Spp., Elisa
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code MJH
FDA has cleared devices under product code MJH between 1992 and 2020, filed by 8 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
- 2020
- 2017
- 2012
- 2007
- 2003
- 1999
- 1998
- 1994
- 1992
Top applicants under product code MJH
Recent clearances under product code MJH
- K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
- K163273 — TRU Legionella
- K113190 — TRU LEGIONELLA
- K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
- K070522 — MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
- K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM
- K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- K982238 — BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
- K934965 — BINAX LEGIONELLA URINARY ANTIGEN EIA
- K911356 — LEGIONELLA STAT IGG/IGM TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.