OIU

Product Code: OIU

Products Classified as OIU

3084

Test, Epithelial Ovarian Tumor Associated Antigen (he4)

Tumor-associated Antigen Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3084

Test, Epithelial Ovarian Tumor Associated Antigen (he4)

Tumor-associated Antigen Immunological Test System.

Pre-market Notifications for OIU

K151378	Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators	Fujirebio Diagnostics, Inc.
K112624	ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5	Roche Diagnostics
K103676	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL	FUJIREBIO DIAGNOSTICS, INC.
K093957	ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,	FUJIREBIO DIAGNOSTICS, INC
K072939	HE4 EIA, MODEL: 404-10 US	FUJIREBIO DIAGNOSTICS, INC.

Global Unique Device Identification Database

• 00380740138349: Test, epithelial ovarian tumor associated antigen (he4)
• 00380740048433: Test, epithelial ovarian tumor associated antigen (he4)
• 00380740003982: Test, epithelial ovarian tumor associated antigen (he4)
• 04987270234174: Test, Epithelial Ovarian Tumor Associated Antigen (He4)
• 17350066140326: Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Maude Adverse Events

ARCHITECT HE4	ABBOTT GERMANY	2019-01-14
ARCHITECT HE4	ABBOTT GERMANY	2016-06-09
ARCHITECT HE4	ABBOTT GERMANY	2015-06-24