Manufacturer's Devices - Stanbio Laboratory

Address:




1261 North Main Street



Boerne

Texas 78006

United States


Authorised Representative/ UK Responsible Person
Name: EKF Diagnostics Holdings plc
Address:

Avon House 19 Stanwell Road

Penarth

Cardiff

CF64 2EZ

Wales United Kingdom



Code/Term Type
Oral/upper respiratory tract specimen collection kit IVD home-useOral/upper respiratory tract specimen collection kit IVD home-useIVD General
Beta-hydroxybutyrate IVD kit enzyme spectrophotometryBeta-hydroxybutyrate IVD kit enzyme spectrophotometryIVD General
Salicylate IVD kit enzyme spectrophotometrySalicylate IVD kit enzyme spectrophotometryIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Sodium (Na+) IVD reagentSodium (Na+) IVD reagentIVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Potassium (K+) IVD reagentPotassium (K+) IVD reagentIVD General
Chloride (Cl-) IVD kit spectrophotometryChloride (Cl-) IVD kit spectrophotometryIVD General
Total bilirubin IVD kit spectrophotometryTotal bilirubin IVD kit spectrophotometryIVD General
Conjugated (direct) bilirubin IVD kit spectrophotometryConjugated (direct) bilirubin IVD kit spectrophotometryIVD General
Albumin IVD kit spectrophotometryAlbumin IVD kit spectrophotometryIVD General
Total protein IVD kit spectrophotometryTotal protein IVD kit spectrophotometryIVD General
Total iron binding capacity (TIBC) IVD kit spectrophotometryTotal iron binding capacity (TIBC) IVD kit spectrophotometryIVD General
Creatinine IVD kit spectrophotometryCreatinine IVD kit spectrophotometryIVD General
Multiple-type clinical chemistry analyte profile IVD calibratorMultiple-type clinical chemistry analyte profile IVD calibratorIVD General
Inorganic phosphate (PO43-) IVD kit spectrophotometryInorganic phosphate (PO43-) IVD kit spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
Uric acid IVD kit spectrophotometryUric acid IVD kit spectrophotometryIVD General
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit rapid agglutination clinicalBeta-haemolytic multiple group Streptococcus streptolysin O antibody IVD kit rapid agglutination clinicalIVD General
C-reactive protein (CRP) IVD kit rapid agglutination clinicalC-reactive protein (CRP) IVD kit rapid agglutination clinicalIVD General
Rheumatoid factor IVD kit agglutinationRheumatoid factor IVD kit agglutinationIVD General
Treponema pallidum reagin antibody IVD kit agglutinationTreponema pallidum reagin antibody IVD kit agglutinationIVD General
Treponema pallidum reagin antibody IVD controlTreponema pallidum reagin antibody IVD controlIVD General
Total human chorionic gonadotropin (HCG) IVD controlTotal human chorionic gonadotropin (HCG) IVD controlIVD General
Multiple urine analyte IVD kit rapid colorimetric clinicalMultiple urine analyte IVD kit rapid colorimetric clinicalIVD General
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidTotal human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapidIVD General
Urea IVD kit enzyme spectrophotometryUrea IVD kit enzyme spectrophotometryIVD General
Magnesium (Mg2+) IVD kit spectrophotometryMagnesium (Mg2+) IVD kit spectrophotometryIVD General