MUREX SUDS TOXO

FDA 510(k)

FDA Class 2 ·Microbiology

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II

FDA 510(k)

FDA Class 2 ·Microbiology

Contact Lens Case

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

QUICKELISA ANTHRAX-PA KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys Anti-HCV II (08837031190)

FDA 510(k)

FDA Class 2 ·Unknown

HYGEIA GC TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GC OIA

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anit-HCV

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 E601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS

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 THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER