Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval

FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

zumax

FDA UDI

Zumax Medical Co., LTD·06945095520078·OT8C Otoscope, handle,Zipper Bag

zumax

FDA UDI

Zumax Medical Co., LTD·06945095520788·OT8C Otoscope head only

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094186314·Welch Allyn Battery Pack for MPT-II Thermal Pri...

GN Otometrics A/S

FDA UDI

Gn Otometrics A/S·05713315000065·

zumax

FDA UDI

Zumax Medical Co., LTD·06945095521983·Otoscope LED bulb,3.5V

Otoscope

FDA UDI

RASHMAN CORPORATION·00786511834203·Standard Pocket Otoscope

Otoscope

FDA UDI

RASHMAN CORPORATION·00786511034207·Standard Pocket Otoscope

GN Otometrics A/S

FDA UDI

Gn Otometrics A/S·05713315000089·

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094082036·Welch Allyn TM286 AutoTymp Pure Tone and Tympan...

zumax

FDA UDI

Zumax Medical Co., LTD·06945095521990·Otoscope bulb,3.5V

zumax

FDA UDI

Zumax Medical Co., LTD·06945095520986·otoscope bulb 2.5V

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094237047·Welch Allyn OAE Hearing Screener Power Supply A...

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094199505·Welch Allyn Probe Tubes for OAE Hearing Screene...

GN Otometrics A/S

FDA UDI

Gn Otometrics A/S·05713315000072·

Otoscope

FDA UDI

RASHMAN CORPORATION·00786511392444·Xenon Pocket Otoscope

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094186215·Welch Allyn OAE Hearing Screener with Charging ...

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094185911·Welch Allyn Charging Stand for OAE Hearing Scre...

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094185935·Welch Allyn MPT-II Thermal Printer for OAE Hear...

zumax

FDA UDI

Zumax Medical Co., LTD·06945095521006·3.5V Otoscope