System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 3 BONE CEMENT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

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

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 411

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV, TEST VERSION 2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT

FDA 510(k)

FDA Class 2 ·Dental

HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

FDA 510(k)

FDA Class 2 ·Immunology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

FDA 510(k)

FDA Class 2 ·Neurology

NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,

FDA 510(k)

FDA Class 2 ·Neurology

6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT

FDA 510(k)

FDA Class 2 ·Immunology

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry