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This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 2 x 0.5mL, L2 x 2 x 0.5mL
In Commercial Distribution
- 00812137012166 ()
- 00812137012449 ()
502-156
- Glycated haemoglobin (HbA1c) IVD, control
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution
- 00812137012074 ()
- 00812137012340 ()
501-420
- Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 120mL, R2 x 2 x 120mL
In Commercial Distribution
- 00812137012012 ()
- 00812137012364 ()
501-414
- Magnesium (Mg2+) IVD, reagent
No Description
Medshape, Inc.
3000-10-32161412
In Commercial Distribution
- M970300010321614120 ()
- Orthopaedic bone staple, non-adjustable
No Description
Medshape, Inc.
3000-10-28161412
In Commercial Distribution
- M970300010281614120 ()
- Orthopaedic bone staple, non-adjustable
No Description
Medshape, Inc.
3000-10-24161412
In Commercial Distribution
- M970300010241614120 ()
- Orthopaedic bone staple, non-adjustable
29MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS29
In Commercial Distribution
- 00690103193732 ()
- 29 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS29A
- Cardiac valvuloplasty catheter
26MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS26
In Commercial Distribution
- 00690103193725 ()
- 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS26A
- Cardiac valvuloplasty catheter
23MM ASCENDRA+ DELIVERY SYSTEM
Edwards Lifesciences LLC
9355AS23
In Commercial Distribution
- 00690103193718 ()
- 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355AS23A
- Cardiac valvuloplasty catheter
EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC25
In Commercial Distribution
- 00690103193459 ()
- 25 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC25A
- Cardiac valvuloplasty catheter
No Description
Edwards Lifesciences LLC
9355FS29
In Commercial Distribution
- 00690103193442 ()
- 29 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS29A
- Cardiac valvuloplasty catheter
No Description
Edwards Lifesciences LLC
9355FS26
In Commercial Distribution
- 00690103193237 ()
- 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS26A
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
No Description
Edwards Lifesciences LLC
9355FS23
In Commercial Distribution
- 00690103193220 ()
- 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS23A
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC23
In Commercial Distribution
- 00690103191820 ()
- 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC23A
- Cardiac valvuloplasty catheter
EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC20
In Commercial Distribution
- 00690103191813 ()
- 20 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC20A
- Cardiac valvuloplasty catheter
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1041-200
Not in Commercial Distribution
- 00848665003826 ()
- Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-200
Not in Commercial Distribution
- 00848665003802 ()
- Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-170
Not in Commercial Distribution
- 00848665003796 ()
- Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-200
Not in Commercial Distribution
- 00848665003741 ()
- Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-170
Not in Commercial Distribution
- 00848665003734 ()
- Femur intramedullary nail