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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

Antigen, Cf, Psittacosis (Chlamydia Group)

FDA classification

FDA Class 1 ·Antigen, Cf, Psittacosis (Chlamydia Group)

Antisera, If, Toxoplasma Gondii

FDA classification

FDA Class 2 ·Antisera, If, Toxoplasma Gondii

Zika Virus Serological Reagents (Emergency Use)

FDA classification

FDA Not Classified ·Zika Virus Serological Reagents (Emergency Use)

Antiserum, Cf, Cytomegalovirus

FDA classification

FDA Class 2 ·Antiserum, Cf, Cytomegalovirus

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA classification

FDA Class 3 ·Antigen(Complexed),Prostate Specific,(Cpsa)

Antiserum, Fluorescent, Mycobacterium Tuberculosis

FDA classification

FDA Class 1 ·Antiserum, Fluorescent, Mycobacterium Tuberculosis

Assay, Direct, Nucleic Acid Amplification, Influenza Virus

FDA classification

FDA Class 1 ·Assay, Direct, Nucleic Acid Amplification, Influenza Virus

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Test, Syphilis, Treponemal

FDA classification

FDA Not Classified ·Test, Syphilis, Treponemal

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

Antisera, Cf, Herpesvirus Hominis 1,2

FDA classification

FDA Class 2 ·Antisera, Cf, Herpesvirus Hominis 1,2

Reagents, Zika Virus Nucleic Acid

FDA classification

FDA Not Classified ·Reagents, Zika Virus Nucleic Acid

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

FDA classification

FDA Not Classified ·Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

FORMAL ALCOHOL

FDA 510(k)

FDA Class 1 ·Pathology

0.85% SALINE

FDA 510(k)

FDA Class 1 ·Pathology

BLUING REAGENT

FDA 510(k)

FDA Class 1 ·Pathology

TRANSPORT CULTURE MEDIUM

FDA 510(k)

FDA Class 1 ·Pathology

DECOLORIZING FLUID

FDA 510(k)

FDA Class 1 ·Pathology

DECOLORIZING FLUIC, ACID-ALCOHOL 3%

FDA 510(k)

FDA Class 1 ·Pathology