Allereye® Tear Total IgE Test Kit

FDA UDI

BLUEJAY DIAGNOSTICS, INC.·00864525000408·Allereye® is a rapid immunoassay for the detect...

Pointe Scientific, Inc.

FDA UDI

POINTE SCIENTIFIC, INC.·00811727013330·IgE for the quantitative determination of Immun...

Hytec Specific/Total IgE EIA

FDA UDI

HYCOR BIOMEDICAL LLC·00816879022100·

QMedix™

FDA UDI

Diagnostic Automation, Inc.·00850054026477·QMedix™Total Human IgE ELISA This test is inten...

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

CLA® Positive Control Serum

FDA UDI

Minaris Medical America, Inc.·00813382010198·CLA Pos Ctrl Serum

OPTIGEN® Negative Control Reagent

FDA UDI

Minaris Medical America, Inc.·00813382010099·OPTIGEN Negative Control

UP20 Positive Control Reagent

FDA UDI

Minaris Medical America, Inc.·00813382010280·UP20 Positive Control Reagent

OPTIGEN® US Panel Control Reagent

FDA UDI

Minaris Medical America, Inc.·00813382010402·KIT, OPTIGEN US Panel Control Reagent

OPTIGEN® Positive Control Reagent

FDA UDI

Minaris Medical America, Inc.·00813382010082·OPTIGEN Positive Control

CLA® Negative Control Serum

FDA UDI

Minaris Medical America, Inc.·00813382010181·CLA Neg Ctrl Serum

UP20 Negative Control Reagent

FDA UDI

Minaris Medical America, Inc.·00813382010358·UP20 Negative Control Reagent

K-ASSAY® Total IgE Calibrator

FDA UDI

KAMIYA BIOMEDICAL COMPANY, LLC·00816426020672·For the calibration of the K-ASSAY® Total IgE a...

IgE CAL SET

FDA UDI

RANDOX LABORATORIES LIMITED·05055273203912·This product is intended for in vitro diagnosti...

ADVIA Centaur® Systems Calibrator 80

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414580111·IgE - CENTAUR - CAL - 2x2x2mL

Atellica IM Calibrator 80

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414598246·Calibrator 80 Atellica IM - CAL (2PK) 2 x 2 x 2...

Visage Ease Pro

FDA registration

Visage Imaging GmbH·1 product·🇩🇪 Germany

NovaSeq 6000Dx Library Tube, 24 pack

FDA registration

SUNNINGDALE TECH LTD·1 product·🇸🇬 Singapore

Solyx SIS Delivery device, Solyx Blue SIS Delivery Device

FDA registration

FIRST ENGINEERING PLASTICS (M) SDN. BHD.·1 product·🇲🇾 Malaysia

ABEL MICROSAMPLER

FDA registration

Diag-Nose Medical Pty Ltd·1 product·🇦🇺 Australia