WHOLE BLOOD MATRIX

FDA UDI

UTAK LABORATORIES, INC.·B800BLKWBFCH0·WHOLE BLOOD MATRIX

FENTANYL NEGATIVE

FDA UDI

UTAK LABORATORIES, INC.·B800FENTNEGFCH0·FENTANYL NEGATIVE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

FITC ANTISERA TO HUMAN LAMBDA

FDA 510(k)

FDA Class 2 ·Immunology

FITC GOAT ANTI-HUMAN KAPPA AFFINITY

FDA 510(k)

FDA Class 2 ·Immunology

FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIMETRIC PLUS KAPPA REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

CHEMMATE(TM) KAPPA

FDA 510(k)

FDA Class 2 ·Immunology

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANTISERUM TO HUMAN KAPPA

FDA 510(k)

FDA Class 2 ·Immunology

AMER. HISTO-ID SYS PRIMARY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay

FDA 510(k)

FDA Class 2 ·Immunology

N Latex FLC kappa, N Latex FLC lambda

FDA 510(k)

FDA Class 2 ·Immunology

IQ LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)

FDA 510(k)

FDA Class 2 ·Immunology

SPOTCHEM II LDH TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

BECKMAN KAPPA LIGHT CHAIN REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

LDH-INT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry