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Bridgeport,
Connecticut, USA (September
11, 1985)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the Glucose
Hexokinase (GLU) in vitro diagnostic chemistry reagent kit. Measurements of
Glucose (GLU) are primarily used for diagnosing diabetes, nephritis, pancreatic
disease, hyperthyroidism, hypopituitarism, hyperinsulinism, cretinism and
myxedema, as well as for monitoring the causes and treatments. Most
of the carbohydrates that people eat are turned into glucose, which can be used
for energy or stored in the liver and kidneys as glycogen. It is the main source
of energy used by the body. Normally, blood glucose levels increase slightly
after a person eats a meal. This increase causes the pancreas to release insulin
so that blood glucose levels do not get too high. Blood glucose levels that
remain high over time can cause damage to the eyes, kidneys, nerves, and blood
vessels. Blood glucose levels are measured to diagnose diabetes or to monitor
its treatment. Blood glucose levels may also be done to evaluate hypoglycemia. A
blood glucose test can be nonfasting (called a random blood sugar) or may be
done after not eating for several hours (called a fasting blood sugar). A
blood glucose test is done on a blood sample taken from a vein or capillary.
Blood Glucose,
Blood sugar, fasting blood sugar, blood glucose is determined when hexokinase
catalyzes the phosphorilation of glucose in the presence of ATP and magnesium
ions. The resultant glucoase-6-phosphate is then oxidized to
6-phosphoglucono lactone with concomitant reduction of nicotinamide adenine
dinucleotide (NAD). The amount of
NADH produced is proportional to the glucose present in the serum sample and it
is quantitated at 340 nm. GLU is a
two reagent chemistry and kits are available in one size and reagents are
available separately. Reagents are
packaged in small glass bottles. Calibrator and controls are available
separately. GLU Kit C122-01 6667 tests, GLU Reagents: GLU R1 C124-01 6x25 ML,
GLU R2 C124-02 6x50 ML. About
Catachem, Inc. Catachem
has a rich 20 year history in clinical chemistry as a manufacturer and
distributor of in-vitro chemistry products and services for 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 and veterinary 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™, Olympus™,
AU Series™, RA Series™, Opera™,
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, Glucose Hexokinase,
GLU, diabetes, nephritis, pancreatic disease,
hyperthyroidism, hypopituitarism, hyperinsulinism, cretinism and myxedema
For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3024a 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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