CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA JO-1 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE-CREACTIVE PROTEIN (LATEX)

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458

FDA 510(k)

FDA Class 2 ·Immunology

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

SERAQUEST VZV IGG

FDA 510(k)

FDA Class 2 ·Microbiology

FERRITIN-LATEX, MODELS 1418-2070, 1418-0279

FDA 510(k)

FDA Class 2 ·Immunology

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS TBI (GFAP, UCH-L1)

FDA 510(k)

FDA Class 2 ·Immunology

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

ERTAPENEM 10UG BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

LYME DISEASE IFA (IGM)

FDA 510(k)

FDA Class 2 ·Microbiology