9,056 results · 31ms · Sources: EU EUDAMED, US FDA

Sweat Control for Cystic Fibrosis Testing

FDA registration
QUANTIMETRIX CORP.·1 product·🇺🇸 United States

Roche ISETROL Control

FDA registration
BIONOSTICS, INC.·1 product·🇺🇸 United States

OPTI-Check Lytes

FDA registration
OPTI MEDICAL SYSTEMS INC.·1 product·🇺🇸 United States

Urine Conductivity Analysis Calibrator, Urine Conductivity Analysis Control

FDA registration
DIRUI INDUSTRIAL CO., LTD.·1 product·🇨🇳 China

In Vitro Diagnostic Medical Devices

FDA registration
INFITEK CO., LTD.·1 product·🇨🇳 China

Phoenix Diagnostics Electrolyte Control

FDA registration
PHOENIX DIAGNOSTICS, INC.·1 product·🇺🇸 United States

Sweat Control Level 1, 2, & 3 Set 9x3mL

FDA UDI
QUANTIMETRIX CORPORATION·00896863002028·The Sweat Controls for Cystic Fibrosis Testing ...

RNA Medical CVC9005 Hematocrit CVC

FDA registration
BIONOSTICS, INC.·2 products·🇺🇸 United States

i-STAT TriControls Control

FDA registration
ABBOTT POINT OF CARE CANADA LIMITED·2 products·🇨🇦 Canada

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AVL ISE-TROL ELECTROLYTE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

QCLYTE PROTEIN-BASED ISE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

STAT-TRAK LIQUID ELECTROLYTE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECTROLYTE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

I-STAT CONTROL LEVELS 1,2,3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry