VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

R&D GLU-LINE HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

Screw, Fixation, Bone

FDA classification

FDA Class 2 ·Screw, Fixation, Bone

Antiserum, Fluorescent, Q Fever

FDA classification

FDA Class 1 ·Antiserum, Fluorescent, Q Fever

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

FDA classification

FDA Class 2 ·Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Antigen, Cf (Including Cf Control), Epstein-Barr Virus

FDA classification

FDA Class 1 ·Antigen, Cf (Including Cf Control), Epstein-Barr Virus

C. Trachomatis (Chlamydia Group)

FDA classification

FDA Class 1 ·C. Trachomatis (Chlamydia Group)

Anti-Jcv Antibody Detection Assay

FDA classification

FDA Class 2 ·Anti-Jcv Antibody Detection Assay

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

FDA classification

FDA Class 2 ·Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

FDA classification

FDA Class 1 ·Antisera, Cf, Equine Encephalitis Virus, Eee, Wee

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Antiserum, Typhus Fever

FDA classification

FDA Class 1 ·Antiserum, Typhus Fever

Internal Polymerase Chain Reaction Control, Not Assay Specific

FDA classification

FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

C. Difficile Nucleic Acid Amplification Test Assay

FDA classification

FDA Class 1 ·C. Difficile Nucleic Acid Amplification Test Assay

Antisera, Fluorescent, Chlamydia Spp.

FDA classification

FDA Class 1 ·Antisera, Fluorescent, Chlamydia Spp.

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

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