Antisera, Fluorescent, All Globulins, Shigella Spp.

FDA classification

FDA Class 2 ·Antisera, Fluorescent, All Globulins, Shigella Spp.

Antisera, Fluorescent, All Groups, N. Meningitidis

FDA classification

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

Antisera, Fluorescent, All Globulins, Salmonella Spp.

FDA classification

FDA Class 2 ·Antisera, Fluorescent, All Globulins, Salmonella Spp.

Antisera, Fluorescent, All Types, Hemophilus Spp.

FDA classification

FDA Class 2 ·Antisera, Fluorescent, All Types, Hemophilus Spp.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

FDA classification

FDA Class 2 ·Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

FDA classification

FDA Class 2 ·Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA 3.0 ASSAY (BDNA)

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Prescription Use Blood Glucose Meter For Near-Patient Testing

FDA classification

FDA Class 2 ·Prescription Use Blood Glucose Meter For Near-Patient Testing

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST VERSION 2.0

Chronic Lymphocytic Leukemia Fish Probe Kit

FDA classification

FDA Class 2 ·Chronic Lymphocytic Leukemia Fish Probe Kit

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Bassinet, Hospital

FDA classification

FDA Class 2 ·Bassinet, Hospital