Product code LHL— Microbiology
DIRECT FA CONJUGATE FOR LEGIONELLA SP
- Classification name
- Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code LHL
FDA has cleared devices under product code LHL between 1981 and 1999, filed by 11 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
- 1999
- 1997
- 1992
- 1987
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code LHL
Recent clearances under product code LHL
- K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
- K970149 — LEGIONELLA ELISA TEST SYSTEM
- K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM
- K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
- K871328 — DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
- K864006 — LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
- K854108 — POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
- K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
- K842683 — GENETIC SYS LEGIONELLA IMMUNOFLURORES
- K832896 — LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
- K831760 — LEGIONELLA IFA KIT I
- K831026 — INDIRECT FLUORESCENT ANTIBODY REAGENTS
- K830820 — LEGIONELLA DFA KIT I
- K822859 — DIRECT FA CONJUGATE FOR LEGIONELLA SPP
- K822066 — LEGIONELLA PNEUMOPHILA
- K813339 — DIRECT FA CONJUGATE FOR LEGIONELLA SP
- K812006 — LEGIONELLA DIRECT FLUORESCENT ANTIBODY
- K812007 — LEGIONELLA INDIRECT FLUOR. ANTIBODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.