QUANTA LITE INTRINSIC FACTOR ELISA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMX B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

1F BLOCKING ANTIBODY(57 CO) RADIOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

REP ALP-15, 8, & 4 KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALKALINE PHOSPHATASE ISOENZY. SUB. SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TITAN GEL ALKALINE PHOSPHATASE (HR)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORION DIAGNOSTICA UNIQ PINP RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS OSTASE IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry