Product code DAE— Immunology
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
- Classification name
- Complement C9, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code DAE
FDA has cleared devices under product code DAE between 1995 and 2015, filed by 5 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
- 2015
- 2012
- 1999
- 1998
- 1995
Top applicants under product code DAE
Recent clearances under product code DAE
- K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
- K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT
- K974111 — QUIDEL CH50 EQ EIA
- K954145 — WAKO AUTOKIT CH50
- K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.