illumigene Pertussis DNA Amplification Assay

FDA 510(k)

FDA Class 2 ·Microbiology

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit

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 Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

FDA 510(k)

FDA Class 2 ·Immunology

AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10

FDA 510(k)

FDA Class 2 ·Immunology

CALCIUM GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NATIVE DNA ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NDNA ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry