Anti-Kpb

FDA UDI

AMERICAN NATIONAL RED CROSS·00858400005039·Blood Grouping Reagent

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

FDA 510(k)

FDA Class 2 ·Cardiovascular

RapidFor™ BNP Rapid Test Kit (FIA)

Device

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

GUAINA COPRITELECAMERA IN PE TRASPARENTE CM.18X300

Device

EU MDR · Eu Md Class 1 ·Surgika srl·On the market

GUAINA COPRITELECAMERA IN PE TRASPARENTE CM.15X300

Device

EU MDR · Eu Md Class 1 ·Surgika srl·On the market

GUAINA COPRITELECAMERA IN PE TRASPARENTE CM.13X300

Device

EU MDR · Eu Md Class 1 ·Surgika srl·On the market

cTnI/D-Dimer/BNP Rapid Quantitative Test

Device

EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

Manifold With Desk Alarm, D (2+1), NP

FDA UDI

ACCUTRON, INC.·00813830022827·

Manifold With Desk Alarm, B (2+2), NP

FDA UDI

ACCUTRON, INC.·00813830022780·

Manifold With Wall Alarm, C (2+1), NP

FDA UDI

ACCUTRON, INC.·00813830022803·

Manifold With Wall Alarm, A (2+2), NP

FDA UDI

ACCUTRON, INC.·00813830022766·

HuaKang

FDA UDI

Anping Huakang Medical Products Factory·06975813110014·

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Anti-nRNP/Sm ELISA (IgG)

FDA registration

EUROIMMUN US INC.·5 products·🇺🇸 United States

Anti-Jo-1 ELISA (IgG)

FDA registration

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·5 products·🇩🇪 Germany