Product code LJM— Immunology
ACCUTEX SLE LATEX TEST
- Classification name
- Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 112
- First cleared
- Most recent
Clearances under product code LJM — page 2
101–112 of 112- K870456 — DNP EIA DIAGNOSTIC KIT
- K870457 — RNP EIA DIAGNOSTIC KIT
- K862969 — ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
- K852840 — ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
- K852230 — ANA/LITE-RL TEST SYSTEM
- K852231 — ANA/LITE-HEP-2 TEST SYSTEM
- K843904 — DNA STAT TEST KIT
- K843745 — ADP ANA APPLEZYME
- K842532 — AMIZYME-ANA TEST KIT
- K842533 — AMIZYME-ANDNA TEST KIT
- K833148 — ENZYME ANA TEST SYSTEM
- K822346 — HISTIMUNE ENZYME-ANA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.