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Device Description : For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Albumin in serum.
Device Class : 2
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Alanine Aminotransferase in serum. ALT is For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative kinetic determination of amylase activity in human serum us For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Aspartate Aminotransferase (AST) in human For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours.Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of direct bilirubin in serum.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of total bilirubin in serum.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Calcium in serum or heparinized plasma. In For the quantitative determination of Calcium in serum or heparinized plasma. Increased serum calcium may be observed in hyperparathyroidism, vitamin D intoxication, multiple myeloma and some neoplastic diseases of bone. Decreased serum calcium may be observed in hypoparathyroidism, vitamin D deficiency, steatorrhea, nephrosis, and nephritis.
Device Class : 2
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No