LCP / ASSAY, GLYCOSYLATED HEMOGLOBIN JJX / Single (specified) analyte controls (assayed and unassayed)

FDA registration

MONOCENT INC.·2 products·🇺🇸 United States

Fructosamine

FDA registration

JAS Diagnostics/Drew Scientific·2 products·🇺🇸 United States

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

artegral life

FDA UDI

Merz Dental GmbH·D7091993590·anteriors; shade BL2; mould IXL

Adtemp 415

FDA registration

AMERICAN DIAGNOSTIC CORP.·1 product·🇺🇸 United States

Bestmed

FDA registration

180 INNOVATIONS LLC·1 product·🇺🇸 United States

CareSens S Fit BT Blood Glucose Monitoring System

FDA registration

I-SENS, INC.·1 product·🇰🇷 South Korea

CareSens S Fit BT Blood Glucose Monitoring System

FDA registration

i-SENS Wonju Factory·1 product·🇰🇷 South Korea

CareSens S Fit BT Blood Glucose Monitoring System

FDA registration

I-SENS Songdo Factory 2·1 product·🇰🇷 South Korea

K-JUMP HEALTH CO., LTD. RENDE PLANT

FDA registration

K-JUMP HEALTH CO., LTD. RENDE PLANT·1 product·🇹🇼 Taiwan

CareSens S Fit BT Blood Glucose Monitoring System

FDA registration

I-SENS USA, INC.·1 product·🇺🇸 United States

DONGGUAN POLYGREEN TECHNOLOGY CO., LTD.

FDA registration

DONGGUAN POLYGREEN TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

K-JUMP HEALTH CO., LTD.

FDA registration

K-JUMP HEALTH CO., LTD.·1 product·🇹🇼 Taiwan

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

CareSens S Fit BT Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLANMECA PROMAX 3D MAX

FDA 510(k)

FDA Class 2 ·Dental

System, X-Ray, Extraoral Source, Digital

FDA classification

FDA Class 2 ·System, X-Ray, Extraoral Source, Digital

System, Test, Blood Glucose, Over The Counter

FDA classification

FDA Class 2 ·System, Test, Blood Glucose, Over The Counter