EIA KIT FOR THE DETECTION OF GBM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

LOVIEL CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDICRAT, HYPODERMIC SYRINGES & NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

FDA 510(k)

FDA Class 2 ·Immunology

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

FDA 510(k)

FDA Class 2 ·Immunology

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

Gemmed pedicle screw spinal system

FDA 510(k)

FDA Class 2 ·Orthopedic

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene Chemdye

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

KARMA-RS, KARMA-FS WHEELCHAIRS

FDA 510(k)

FDA Class 2 ·Physical Medicine