ELECYS IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE TOTAL IGE

FDA 510(k)

FDA Class 2 ·Immunology

IMMILITE TOTAL IGE

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS IGE II IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TURBO-RAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

FDA 510(k)

FDA Class 2 ·Immunology

Radioimmunoassay, Immunoglobulins (D, E)

FDA classification

FDA Class 2 ·Radioimmunoassay, Immunoglobulins (D, E)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSOAK

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)

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

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·GEOPEN SUSCEPTIBILITY POWDER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSRINS(R) STERILE PRESERVED SALINE SOLN

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) DW (HEFILICON A) CONTACT LENS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·AUTOBAC MTS PLUS TEST SYTEM

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)