Catachem Announces FDA Approval of the Blood Urea Nitrogen (BUN) In-Vitro

Thursday 1st of January 1970 1:00

Catachem Announces FDA Approval of the Blood Urea Nitrogen (BUN) In-Vitro Diagnostic (IVD) Chemistry Reagent Kit

Bridgeport, Connecticut, USA (June 7, 1989)…. Catachem, Inc. (Private) announced today that it has received 510k clearance from the United States Food and Drug Administration (FDA) for the Blood Urea Nitrogen (BUN) in vitro diagnostic chemistry reagent kit.

Measurements of Blood Urea Nitrogen (BUN) activity are primarily used for diagnosing cardiac decompensation, increased protein catabolism, glomerulo-nephritis, chronic nephritis, polycystic kidney, nephrosclerosis, obstruction of the urinary tract, as well as for monitoring the causes and treatments. A blood urea nitrogen (BUN) test measures the amount of nitrogen in the blood that comes from urea. Urea is a waste product formed when protein is broken down in the body. It is produced in the liver and eliminated from the body in urine. A BUN test is done to estimate how well the kidneys are functioning. If the kidneys are not able to remove urea from the blood normally, the BUN level increases. Heart failure, dehydration, or a diet high in protein can also increase the BUN level. Liver disease or damage can decrease the BUN level, because urea is made in the liver. A decreased BUN level can occur normally in the second or third trimester of pregnancy. A BUN test may be done along with a blood creatinine test. The level of creatinine in the blood provides information on how well the kidneys are working. A high creatinine level may mean the kidneys are not working properly. The measured blood urea nitrogen (BUN) and creatinine tests can be used to calculate the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help a physician predict which conditions (such as dehydration) may be causing abnormal BUN and creatinine levels and decreased kidney function. A BUN test is done on a sample of blood taken from a vein.  Urease hydrolyzes urea to ammonia and carbon dioxide.  The ammonia produced is quantitatively determined by the GLDH-NADH reaction.  The decrease in absorbance due to the oxidation of NADH to NAD is monitored at 340 nm.  BUN is a one reagent chemistry available in four sizes. Reagents are packaged in small glass bottles. BUN C264-01 6x25 ML, BUN C264-02 6x50 ML, BUN C262-01 4x500 ML, BUN C262-02 5x250 ML.

About Catachem, Inc.

Founded in 1984 Catachem has a rich 20 year history in clinical chemistry as a manufacturer and distributor of in-vitro chemistry products and services for assays in human, veterinary and environmental laboratories. Catachem chemists helped develop many of the automated diagnostic chemistries widely in use today.  Catachem created the DiscretePak™ and VetSpec™ line of reagents for human diagnostic and veterinary diagnostic automated analyzers.  Catachem offers FDA approved (510K) chemistries (liquid and dry) including enzymatic chemistries developed in conjunction with IFCC and CDC.  Catachem has more than 500 applications for all types of analyzers including the Roche™ Hitachi™ series, Olympus™ AU Series™, RA Series™, Opera™ and DAX™, Bayer™ Advia™, Synchron™, Beckman™, Abbott™ and many other analyzers.  Corporate headquarters, research, custom formulation laboratories, and manufacturing are located in Bridgeport, Connecticut.  Catachem supplies leading laboratories and equipment manufacturers from distributors around the world. 

Forward-looking statements in this release are made pursuant to the ``safe harbor'' provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.

Keywords: Catachem, Chemistry, Reagents, In-Vitro Diagnostics, IVD, the Blood Urea Nitrogen, BUN, cardiac decompensation, increased protein catabolism, glomerulo-nephritis, chronic nephritis, polycystic kidney, nephrosclerosis, urinary tract

For more information contact:

Benjamin Twombly

Catachem, Inc.
70 Hawley Avenue
Bridgeport, CT
USA 06606
+1 (203) 335-9277 Office
+1 (203) 335-9977 FAX
bentwombly@aol.com
catachem@aol.com
www.catacheminc.com

Ref: C3109a

Catachem chemistries include: 5'-Nucleotidase (5NT), Adenosine Deaminase (ADA), Alanine Aminotransferase (ALT), Albumin BCG (ALB), a-L-Fucosidase (AFU), Alkaline Phosphatase (ALP), Ammonia (NH), Amylase (AMY), Aspartate Aminotransferase (ALP), β-Hydroxybutyrate (BHBA), Bicarbonate (HC03), Bile Acids (BA), Bilirubin, Direct with Blank (DBILI), Bilirubin, Total with Blank (TBILI), Bilirubin, Total (TBILI), Blood Urea Nitrogen (BUN), Bromide (BR), CO2 [340] (CO2), CO2 [380] (CO2), CO2 [single reagent] (CO2), Ca+++ Arsenazo [650NM] (CA3), Chloride [340 NM] (CL), Cholesterol (CH), Creatine Kinase (CK), Creatinine (CREAT), Fructosamine [millimole method] (FR), Fructosamine, Glycated Serum Protein [enzymatic] (FR), Gamma-Glutamyl Transpeptidase (GGT), Glucose Hexokinase (GLU), Glycated Hemoglobin (HbA1c), High Density Lipoproteins, Dextran Sulfate (HDL), Inorganic Phosphorus (IP), Lactate Dehydrogenase (LD), Lipase (LIP), Lithium [enzymatic] (LI), Magnesium (MG), N-Acetyl-ß-D-glucosaminidase (NAG), Potassium [enzymatic] (K), Plasma Free Hemoglobin (PFH), Pre-albumin (TBPA), Sodium [enzymatic] (NA), Sorbitol Dehydrogenase (SDH), Thiopurine methyltransferase (TPMT), Total Bile Acids (TBA), Total Iron (TI), Total Protein (TP), Triglycerides (TRIG), UIBC and TIBC (UIBC), Uric Acid (UA), Vitamin B6 (V6B), Multipoint Calibrator Catacal, Catatrol Level 1 Catatrol Level 2, Bile Acids Control, Bile Acids Calibrator, BHBA Calibrator, BHBA Control Level 1, BHBA Control Level 2; Bromide Calibrator, BR Control Level 1, BR Control Level 2; Fructosamine Calibrator, FR Control Level 1, FR Control Level 2, SDH Control Level 1, SDH  Control Level 2.  Call +1 (203) 335-9277 or Write Catachem@aol.com.
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