BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

FDA 510(k)

FDA Class 1 ·Microbiology

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA

FDA 510(k)

FDA Class 1 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBe2 (aHBe2) assay

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS

I3 BioMedical Inc.

Manufacturer

🇨🇦 Canada

Coroneo Inc.

Manufacturer

🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS

Shining World Health Care Co., Ltd.

Manufacturer

🇹🇼 Taiwan·1 Importer

Tanaphar Joint Stock Company

Manufacturer

🇻🇳 Vietnam

Chemo Mouthpiece LLC

Manufacturer

🇺🇸 United States

Optoacoustics Ltd.

Manufacturer

🇮🇱 Israel

Osteopore International Pte Ltd

Manufacturer

🇸🇬 Singapore·5 Importers·TÜV Rheinland LGA Products GmbH

PREVEST DENPRO LIMITED

Manufacturer

🇮🇳 India

Incrediwear Holdings, Inc.

Manufacturer

🇺🇸 United States·4 Basic UDI-DIs·210 Devices·1 Importer

SELVAS Healthcare, Inc.

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·1 Importer·TÜV Rheinland LGA Products GmbH

Aptis Medical, LLC

Manufacturer

🇺🇸 United States·2 Importers

Sahajanand Medical Technologies Limited

Manufacturer

🇮🇳 India·642 Basic UDI-DIs·642 Devices·2 Importers·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

ELLTEC Co., Ltd.

Manufacturer

🇯🇵 Japan·1 Importer

Bio-Art Equipamentos Odontológicos Ltda.

Manufacturer

🇧🇷 Brazil·1 Importer

Micropoint Bioscience, Inc.

Manufacturer

🇺🇸 United States