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Bridgeport,
Connecticut, USA (November 25, 1988)…. Catachem, Inc. (Catachem, Private) announced
today that it has received 510k clearance from the United States Food and Drug
Administration (FDA) for the Alanine Aminotransferase (serum
glutamic-pyruvic transaminase, SGPT, ALT) in
vitro diagnostic chemistry reagent kit. Measurements
of Alanine Aminotransferase (ALT) activity provide information for diagnosing
liver and heart diseases, as well as, for monitoring the causes and treatment.
ALT is
an enzyme found mainly in the liver, but also in smaller amounts in the kidneys,
heart, muscles, and pancreas. ALT formerly was called serum glutamic pyruvic
transaminase (SGPT). ALT is
measured to determine whether the liver is damaged or diseased. Low levels of
ALT are normally found in the blood. However, when the liver is damaged or
diseased, it releases ALT into the bloodstream, causing levels of the enzyme to
rise. Although ALT is found in organs other than the liver, most increases in
ALT levels are due to liver damage. The
ALT test often is done along with other tests that can determine whether the
liver is damaged, including aspartate aminotransferase (AST), alkaline
phosphatase, lactate dehydrogenase (LDH), and bilirubin. Both ALT and AST levels
are reliable indicators of liver damage. This test is done on a blood sample taken from a vein.
Serum glutamic-pyruvic transaminase (SGPT), Alanineaminotransferase (ALT) enzyme catalyzes the conversion of
alphaketoglutarate and L-glutamate and pyruvate. The pyruvate produced is then
quantitatively determined by the LDH-NADH reaction. The decrease in absorbance due to the oxidation of NADH to
NAD is monitored at 340 nm. The
rate of decrease in absorbance of the reaction mixture is directly proportional
to the ALT enzyme activity in the serum sample. ALT is a one reagent
chemistry available in four sizes. Reagents are packaged in small glass bottles.
Calibrator and controls are available separately. ALT Kit C164-01 6x25 mL; ALT
Kit C164-02 6x50 mL; ALT Kit C152-01 4x500 mL; ALT Kit C152-02 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, Alanine aminotransferase, ALT, serum glutamic pyruvic transaminase, SGPT For
more information contact: Benjamin Twombly 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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