Antigens, Nontreponemal, All

FDA classification

FDA Class 2 ·Antigens, Nontreponemal, All

Antisera, All Leptospira Spp.

FDA classification

FDA Class 2 ·Antisera, All Leptospira Spp.

Antigens, All, Leptospira Spp.

FDA classification

FDA Class 2 ·Antigens, All, Leptospira Spp.

Antigens, Histoplasma Capsulatum, All

FDA classification

FDA Class 2 ·Antigens, Histoplasma Capsulatum, All

Antigens, All Groups, Shigella Spp.

FDA classification

FDA Class 2 ·Antigens, All Groups, Shigella Spp.

Antiserum, Vibrio Cholerae, All Varieties

FDA classification

FDA Class 2 ·Antiserum, Vibrio Cholerae, All Varieties

Antigens, All Groups, Salmonella Spp.

FDA classification

FDA Class 2 ·Antigens, All Groups, Salmonella Spp.

Antisera, All Groups, Salmonella Spp.

FDA classification

FDA Class 2 ·Antisera, All Groups, Salmonella Spp.

Antisera, All Types, H. Influenza

FDA classification

FDA Class 2 ·Antisera, All Types, H. Influenza

Antisera, All Types, Shigella Spp.

FDA classification

FDA Class 2 ·Antisera, All Types, Shigella Spp.

Antisera, All Groups, N. Meningitidis

FDA classification

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

Antisera, All Fluorescent, Leptospira Spp.

FDA classification

FDA Class 2 ·Antisera, All Fluorescent, Leptospira Spp.

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Aptima CMV Quant Assay