881 results · 43ms · Sources: EU EUDAMED, US FDA

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

FDA classification
FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Kit, Screening, Trichomonas

FDA classification
FDA Class 1 ·Kit, Screening, Trichomonas

Fibrinopeptide A, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Fibrinopeptide A, Antigen, Antiserum, Control

Biosensor, Immunoassay, Myoglobin

FDA classification
FDA Class 2 ·Biosensor, Immunoassay, Myoglobin

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

FDA classification
FDA Class 1 ·Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA classification
FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Antiserum, Positive Control, Histoplasma Capsulatum

FDA classification
FDA Class 2 ·Antiserum, Positive Control, Histoplasma Capsulatum

Antiserum, Fluorescent, C. Diphtheriae

FDA classification
FDA Class 1 ·Antiserum, Fluorescent, C. Diphtheriae

Antisera, Control For Nontreponemal Tests

FDA classification
FDA Class 2 ·Antisera, Control For Nontreponemal Tests

Antisera, All Types, Streptococcus Pneumoniae

FDA classification
FDA Class 1 ·Antisera, All Types, Streptococcus Pneumoniae

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA classification
FDA Class 2 ·Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Hemopexin, Fitc, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Hemopexin, Fitc, Antigen, Antiserum, Control

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

FDA classification
FDA Class 1 ·Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA classification
FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Serpina1 Variant Detection System

FDA classification
FDA Class 2 ·Serpina1 Variant Detection System

Antisera, Conjugated Fluorescent, Cytomegalovirus

FDA classification
FDA Class 2 ·Antisera, Conjugated Fluorescent, Cytomegalovirus

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

FDA classification
FDA Class 2 ·Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Sera, Reactive And Non-Specific Control, Fta-Abs Test

FDA classification
FDA Class 2 ·Sera, Reactive And Non-Specific Control, Fta-Abs Test

Antisera, All Groups, N. Meningitidis

FDA classification
FDA Class 2 ·Antisera, All Groups, N. Meningitidis