Product code LSW— Immunology
AESKULISA DS DNA G
- Classification name
- Anti-Dna Antibody, Antigen And Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LSW
FDA has cleared devices under product code LSW between 1987 and 2018, filed by 7 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
- 2018
- 2016
- 2008
- 2007
- 2006
- 2004
- 1993
- 1987
Top applicants under product code LSW
Recent clearances under product code LSW
- K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
- K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K081251 — MODIFICATION TO AESKULISA DS DNA G
- K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
- K060380 — FIDIS DSDNA
- K041628 — AESKULISA DS DNA G
- K921658 — ANTI-DSDNA ANTIBODY TEST
- K872085 — THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.