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Bridgeport,
Connecticut, USA (February
20, 1986)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the Lactate Dehydrogenase (LD) in vitro diagnostic chemistry reagent kit. Measurements of
Lactate Dehydrogenase (LD) activity are primarily used for diagnosing myocardial
infarctions, myocarditis, cardiac failure with hepatic congestion, liver
disease, pernicious anemia, megaloblastic anemia and renal disease, as well as
for monitoring the causes and treatments. During a heart attack (or myocardial
infarction), damaged heart tissue releases specific proteins called cardiac
enzymes. One way to diagnose or confirm a recent heart attack is to test a
person's blood for increased levels of these enzymes. The main enzymes that are measured are troponin I, creatine
phosphokinase (CPK, CK), and lactate dehydrogenase (lactic acid dehydrogenase,
LDH). Low levels of these enzymes are normally found in your bloodstream, but if
your heart muscle is injured (as in a heart attack), the enzymes leak out of
damaged heart muscle cells and their levels in the blood rise. CPK is found in
the heart muscle, liver, skeletal muscles (such as in the arms and legs), and in
the brain. LDH is found in many other body tissues, including the liver,
kidneys, skeletal muscles, the brain, and lungs. CPK-MB is a subtype of CPK that
is found only in heart muscle. LDH-1 is a subtype of LDH that is found mainly in
red blood cells and in heart muscle. Some of these enzymes are also found in
other parts of the body besides heart muscle, and their levels in the blood may
rise when those other tissues are damaged. However, troponin I is released only
by heart muscle. Cardiac enzyme studies must always be interpreted in light of
your symptoms, your physical exam findings, and electrocardiography (EKG)
results. All of these tests are
done on a sample of blood taken from a vein. LD, Lactate dehydrogenase, Total
LDH, and LDH isoenzymes, total and isoenzymes and lactate dehydrogenase (EC 1.1.1.27; L-lactate: NAD oxido reductase) is an
enzyme which catalyzes the oxidation of L-lactate to pyruvate with the mediation
of NAD as a hydrogen acceptor. The
reaction is reversible and strongly favors the conversion of pyruvate to
lactate. The rate of increase in
absorbance of the reaction mixture due to the formation of NADH is proportional
to the LD concentration present in the serum sample. LD is a two reagent
chemistry available in two sizes. Reagents
are packaged in small glass bottles. Calibrator and controls are available
separately. LD R1 C144-01 6x25 ML, LD R2 C144-02 6x50 ML, LD R1 C142-01 4x500
ML, LD R2 C142-02 5x250 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, Lactate Dehydrogenase (Total LDH, LDH isoenzymes, Total and Isoenzymes,
LD, myocardial infarctions, myocarditis, cardiac failure with hepatic
congestion, liver disease, pernicious anemia, megaloblastic anemia, renal
disease For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3025a 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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