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FDA Pre-Market Approval
GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

no MS (ISE Reference Electrolyte)

FDA UDI
Roche Diagnostics GmbH·04015630915064·

N Antiserum to Human a1-Antitrypsin

FDA UDI
Siemens Healthcare Diagnostics Products GmbH·00842768009921·Quantitative determination of a1-antitrypsin in...

Potassium Electrode

FDA UDI
MEDICA CORPORATION·00386100002466·Potassium Electrode for use with EasyStat and E...

cobas b 221 <6> system

FDA UDI
Roche Diagnostics GmbH·04015630018345·

Alinity

FDA UDI
ABBOTT LABORATORIES·00380740153519·Alinity c A1-Antitrypsin Reagent Kit 200 Tests

K-ASSAY® Alpha-1 AT Reagent

FDA UDI
KAMIYA BIOMEDICAL COMPANY, LLC·00816426020009·For the quantitative determination of human alp...

Antiserum to Alpha 1 Antitrypsin

FDA UDI
KENT LABORATORIES INC·B1761220·goat antiserum to Human Alpha 1 Antitrypsin

VITROS

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002290·VITROS Chemistry Products AAT Reagent

Accelerator a3600

FDA UDI
Inpeco SA·07640172341001·The Accelerator a3600 automation is a modular s...

STAT PROFILE

FDA UDI
NOVA BIOMEDICAL CORPORATION·00385480485821·Stat Profile Ultra/CCX Potassium Sensor

Potassium Electrode

FDA UDI
Roche Diagnostics GmbH·04015630918737·

Albumin BCP

FDA UDI
Roche Diagnostics GmbH·04015630927562·

I.S.E. K

FDA UDI
RANDOX LABORATORIES LIMITED·05055273210538·Intended for use with the Ion Selective Electro...

IMMAGE

FDA UDI
Beckman Coulter, Inc.·15099590224042·IMMAGE Immunochemistry Systems AAT Alpha-1-Anti...

cobas b 221 <2> system

FDA UDI
Roche Diagnostics GmbH·04015630018307·

Potassium Electrode

FDA UDI
Diamond Diagnostics Inc.·00811403010127·Measuring concentration of Potassium in whole b...

K ELECTRODE, ISE MODULE

FDA UDI
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag·05999883586693·Clinical Chemistry Test Systems / Potassium te...

VITROS

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750010233·VITROS Chemistry Products K+ Slides

K (Potassium) Electrode

FDA UDI
TOKYO BOEKI MEDISYS INC.·04580262010277·