LEUKOCYTES, Urine Test Strips, UTI Test Strips

FDA registration

Changchun LYZ Technology Co.,LTD·1 product·🇨🇳 China

B1 Vomitoxin QuantitativeTest(Time-Res Olvedfuoroimmunoassay)

FDA registration

CHANGCHUN MERYDI BIO-TECH CO., LTD.·1 product·🇨🇳 China

Thyroxine Detection Kit

FDA registration

DIRUI INDUSTRIAL CO., LTD.·1 product·🇨🇳 China

diazonium colorimetry, urobilinogen (urinary, non-quant.)

FDA registration

CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·1 product·🇨🇳 China

Glutathione Reductase Reagent Kit (Glutathione Substrate Assay)

FDA registration

DIRUI INDUSTRIAL CO., LTD.·1 product·🇨🇳 China

Vaginal PH Test Strip

FDA registration

CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·1 product·🇨🇳 China

Uric Acid test

FDA registration

CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·1 product·🇨🇳 China

Zearalenone Quantitative Test(Time-ResolvedfluoroimmunoasSay)

FDA registration

CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·1 product·🇨🇳 China

Bromine, Fluoride, Arsenic, COD, Ammonia, Copper, Phosphorus, Iron, Chromium, Nitrogen, Zinc, MPS, H2O2, PHMG,

FDA registration

JILIN TEST BIO-ELECTRON CO.,LTD·1 product·🇨🇳 China

Apoller

FDA registration

SINO-DENTEX CO.,LTD·1 product·🇨🇳 China

CS Series Chemistry Analyzer, Various names and models

FDA registration

DIRUI INDUSTRIAL CO., LTD.·1 product·🇨🇳 China

Dehydroepiandrosterone Detection Kit (Chemiluminescence Immunoassay)

FDA registration

DIRUI INDUSTRIAL CO., LTD.·1 product·🇨🇳 China

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

AIV

FDA UDI

AMERICAN IV PRODUCTS, INC.·M745BX10469·Assembly Door 1 Baxter

LABSYSTEM™ PRO

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506004392·LABSYSTEM™ PRO EP Review Workstation Software

Eko Analysis Software

FDA UDI

Eko Devices, Inc.·00850010298030·The Eko Analysis Software is intended to provid...

Garmin ECG App

FDA UDI

Garmin International, Inc.·00860009117709·

Fitbit Irregular Rhythm Notifications

FDA UDI

FITBIT, INC.·00810038852720·The Fitbit Irregular Rhythm Notifications is a ...

ECG 2.0 App

FDA UDI

APPLE INC.·00190199649286·ECG Watch App (version 2.0)

ECG-AI LEF

FDA UDI

Anumana, Inc.·00860007426407·The Low Ejection Fraction AI-ECG Algorithm inte...