TOXO IPA KIT IAN INDIRECT FLUORESCENT

FDA 510(k)

FDA Class 2 ·Microbiology

TOXOPLASMA ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

TOXELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECT ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV ASSAY

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

NG-Test CARBA 5

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

ELISA CMV IGM

FDA 510(k)

FDA Class 2 ·Microbiology

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

FDA 510(k)

FDA Class 2 ·Microbiology

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

FDA 510(k)

FDA Class 2 ·Microbiology

CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ENZYGNOST ANTI-CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS CMV IGM ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology