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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. 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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