Wal-Star, Inc.

FDA UDI

Wal-Star, Inc.·00850054416797·

SOFIA(R) RSV FIA

FDA 510(k)

FDA Class 1 ·Microbiology

QUANTIMUNE T-3 FIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUANTIMUNE T-4 FIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sofia 2 Campylobacter FIA

FDA 510(k)

FDA Class 1 ·Microbiology

SOFIA(R) HCG FIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOFIA STREP A FIA

FDA 510(k)

FDA Class 1 ·Microbiology

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

SOFIA INFLUENZA A+B FIA

FDA 510(k)

FDA Class 1 ·Microbiology

Sofia Influenza A+B FIA

FDA 510(k)

FDA Class 2 ·Microbiology

SOFIA (R) STREP A+ FIA

FDA 510(k)

FDA Class 1 ·Microbiology

OnSite hCG Combo Rapid Test (REF# R1001S)

FDA registration

CTK BIOTECH, INC.·1 product·🇺🇸 United States

Syphilis FIA

Device

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

Norovirus FIA

Device

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

Astrovirus FIA

Device

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

Rotavirus FIA

Device

EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market