ARBOVIRUS IGG IFA TEST

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNODIFFUSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES ANTIGEN #CF10023X

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN RESPIRATORY SCREEN

FDA 510(k)

FDA Class 1 ·Microbiology

DFA RESPIRATORY VIRUS SCREENING & ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

FDA 510(k)

FDA Class 1 ·Microbiology

D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

FDA 510(k)

FDA Class 1 ·Microbiology

Pansements en bambou

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Artis CF·1 device

Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Albumin, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Albumin, Antigen, Antiserum, Control

Instrument, Biopsy, Mechanical, Gastrointestinal

FDA classification

FDA Class 2 ·Instrument, Biopsy, Mechanical, Gastrointestinal

Mask, Surgical, Eua Authorized

FDA classification

FDA Not Classified ·Mask, Surgical, Eua Authorized

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

COXSACKIE A2 CF ANTIGEN, A4, A10 & A16

FDA 510(k)

FDA Class 1 ·Microbiology

Nettle

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Samphire Neuroscience Ltd·1 device

Aluderm 60ml Hydrogel

Basic UDI-DI

EU MDD · Eu Md Class 2a ·CF Pharma Ireland Ltd·1 device