LEGEND

FDA UDI

Gc Orthodontics America Inc.·D78827113D00121·LGM ROTH SP 018/UR3 -2T 9A 4M HK

LEGACY

FDA UDI

Gc Orthodontics America Inc.·D788271CC500101·LGM ROTH 018 U/L 5-5 HK 345

7950 MASK

FDA UDI

HANS RUDOLPH, INC.·00817136022413·PED LG M/F MASK W/ADPT MGC PNT

7950 MASK

FDA UDI

HANS RUDOLPH, INC.·00817136020419·7950 PED LG M/F MASK W/2630 2W

7950 MASK

FDA UDI

HANS RUDOLPH, INC.·00817136020426·7950 PED LG M/F MASK W/2600 2W

LEGEND

FDA UDI

Gc Orthodontics America Inc.·D78827123D00121·LGM ROTH SP 018/UL3 -2T 9A 4M HK

HAV lgM Rapid Test

Device

EU IVDD · Eu Ivd General ·Beijing Jinwofu Bioengineering Technology Co., Ltd.·On the market

RAPI/TEX-LGM KIT

FDA 510(k)

FDA Class 2 ·Immunology

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc lgM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT

FDA 510(k)

FDA Class 1 ·Microbiology

RapidFor™ SARS-CoV-2 lgG/lgM Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ SARS-CoV-2 lgG/lgM Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

ISOLATION MASK I.C.S.

FDA 510(k)

FDA Class 2 ·General Hospital

INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 7-AT TREATMENT CHAMBER

FDA 510(k)

FDA Class 2 ·General Hospital

MTB 1043 TREATMENT BOOTH

FDA 510(k)

FDA Class 2 ·General Hospital

PATIENT ISOLATION UNIT, MODEL G019-1000

FDA 510(k)

FDA Class 2 ·General Hospital

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital