PAX-DUO3D PLUS, PCT-5000

FDA 510(k)

FDA Class 2 ·Radiology

Pro-Tx Endorectal Balloon (PROT-25)

FDA 510(k)

FDA Class 2 ·Radiology

RectalPro 75 Endorectal Balloon

FDA 510(k)

FDA Class 2 ·Radiology

Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301

FDA 510(k)

FDA Class 2 ·Radiology

ERB ENDORECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

PROSTATE IMMOBILIZER RECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

PaX-i3D Green Premium (Model: PCT-90LH)

FDA 510(k)

FDA Class 2 ·Radiology

B-R-A-H-M-S PCT LIA

FDA 510(k)

FDA Class 2 ·Microbiology

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

B R A H M S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

FDA 510(k)

FDA Class 2 ·Microbiology

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM

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

Antigen, Inflammatory Response Marker, Sepsis

FDA classification

FDA Class 2 ·Antigen, Inflammatory Response Marker, Sepsis

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

FDA classification

FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Prostate Immobilizer Rectal Balloon

FDA classification

FDA Class 2 ·Prostate Immobilizer Rectal Balloon

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification

FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology