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

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

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

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