Sunday July 05 2009 | Biotechnology feed | All feeds
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Sunday July 05 2009 | Biotechnology feed | All feeds
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Bridgeport,
Connecticut, USA (January 12, 1989)…. Catachem, Inc. (Private) announced today
that it has received 510k clearance from the United States Food and Drug
Administration (FDA) for the Aspartate Aminotransferase (glutamic
oxaloacetic transaminase, SGOT, AST) in
vitro diagnostic chemistry reagent kit. Measurements of
Aspartate Aminotransferase (AST) activity are used for diagnosing liver and
heart diseases, as well as, for monitoring the causes and treatment.
AST is an enzyme found mainly in liver, heart, red blood cells, and
muscle tissue. It also is found in other organs, such as the pancreas and
kidneys. AST formerly was called serum glutamic oxaloacetic transaminase (SGOT).
When an organ (such as the heart or liver) or body tissue is diseased or
damaged, additional AST is released into the bloodstream. The amount of AST in
the blood is directly related to the extent of the tissue damage. After severe
damage, AST levels rise in 6 to 10 hours and remain high for about 4 days. The
AST test may be done at the same time as a test for alanine aminotransferase, or
ALT. The ratio of AST to ALT (AST:ALT) sometimes can help determine whether the
liver or another organ has been damaged. AST also can help determine the cause
of the liver damage. Both ALT and AST levels are reliable indicators of liver
damage. This test is done on a blood sample taken from a vein. Sometimes blood
samples for AST testing are collected each day for several days in a row, to
determine if the AST level is going up or down. Serum glutamic-oxaloacetic transaminase (SGOT) Aspartate aminotransferase enzyme catalyzes the conversion of alpha-ketoglutarate
and L-aspartate to L-glutamate and oxalacetate. The oxalacetate produced is then quantitatively determined by
the MDH-NADH reaction. The decrease
in absorbance due to the oxidation of NADH to NAD is monitored at 340nm.
The rate of decrease in absorbance of the reaction mixture is directly
proportional to the AST enzyme activity in the serum sample.
AST is a one reagent
chemistry available in four sizes. Reagents
are packaged in small glass
bottles. Calibrator and controls are available separately. AST Kit C154-01 6x25 ML, AST Kit C154-02 6x50 ML, AST Kit
C152-01 4x500 ML, AST Kit C152-02 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, Aspartate
aminotransferase, glutamic oxaloacetic transaminase, SGOT, AST,
liver and heart diseases For
more information contact: Benjamin
Twombly Catachem,
Inc. Ref:
C3015d 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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