BLOOD KIT, SEXUAL ASSAULT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEBULIZATION KIT & ADAPTER KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Kit Boxes and Kit Plates

FDA 510(k)

FDA Class 2 ·General Hospital

CHEM KIT THEOPHYLLINE DIAG. KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REDLINE ANTHRAX ALERT TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

FDA 510(k)

FDA Class 2 ·Immunology

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)

FDA Class 2 ·Immunology

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

FDA 510(k)

FDA Class 2 ·Immunology

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136

FDA 510(k)

FDA Class 2 ·Hematology

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE A1AT kit

FDA 510(k)

FDA Class 2 ·Immunology

ICATH, STERILESURE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

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

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0