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CAPI 3 IMMUNOTYPING

FDA UDI
SEBIA·03607360026007·Device designed for the qualitative detection a...

IT/IF Control

FDA UDI
SEBIA·03607360023006·Control for the detection and characterization ...

URINE REAGENT STRIP-3

FDA registration
TECO DIAGNOSTICS·3 products·🇺🇸 United States

IR / INDICATOR METHOD, PROTEIN OR ALBUMIN, GLUCOSE, PH

FDA registration
MONOCENT INC.·3 products·🇺🇸 United States

Stat Profile Prime ABG Analyzer

FDA registration
NOVA BIOMEDICAL CORPORATION·3 products·🇺🇸 United States

Stat Profile Prime ES Comp Plus Analyzer System

FDA registration
Nova Biomedical Corporation·4 products·🇺🇸 United States

OPTI CCA-TS B-Lac

FDA registration
OPTI MEDICAL SYSTEMS INC.·4 products·🇺🇸 United States

Urine strip reagents

FDA registration
Diagnostic Automation/ Cortez Diagnostics Inc,.·3 products·🇺🇸 United States

Stat Profile Prime ES Comp Plus Analyzer System

FDA registration
NOVA BIOMEDICAL CORPORATION·4 products·🇺🇸 United States

Stat Profile Prime ABG Analyzer

FDA registration
Nova Biomedical Corporation·3 products·🇺🇸 United States

FEMEXAM TESTCARD

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FOLATE/B12 DUO-BEAD RADIOASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VS-SENSE TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

URINE SCREENING KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HELENA BIOSTRIP PH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

KYOTEST 5V

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

QUICKVUE ADVANCE PH AND AMINES GLL TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AMNISCREEN HOME DETECTION LINER KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AIMSTICK URINE REAGENT STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry