AMIZYME-HSV TYPES 1 & 2 TEST KITS

FDA 510(k)

FDA Class 2 ·Microbiology

CONTROL SERUMS FOR NONTREPONEMAL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOSET IMMUNOPEROFIDASE TISSUE

FDA 510(k)

FDA Class 2 ·Microbiology

CYTOMEGALOVIRUS IGG EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MUELLER HINTON

FDA 510(k)

FDA Class 2 ·Microbiology

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

MARTIN-LEWIS AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

COCCIDIOIDES MYCELIAL ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

ABBOTT HSV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

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