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Bridgeport,
Connecticut, USA (April 24, 1986)…. Catachem, Inc. (Catachem, Private)
announced today that it has received 510k clearance from the United States Food
and Drug Administration (FDA) for the Triglycerides (TRIG) in vitro diagnostic chemistry
reagent kit. Determination of
Triglycerides (TRIG) are primarily used for diagnosing atherosclerosis and heart
disease, diabetes mellitus, nephritis, biliary obstruction and metabolic
disorders associated with endocrine disturbances, as well as for monitoring the
causes and treatments. Triglycerides
are a type of fat the body uses to store energy. Only a small amount of
triglycerides are found in the blood. A high triglyceride level along with high
LDL cholesterol may be more of a risk for heart disease than having only a high
LDL cholesterol level. All of these
tests are done on a sample of blood taken from a vein. TG, TRIG, or serum triglycerides are hydrolyzed by microbial lipase to glycerol and free
fatty acids. The resultant
glycerol, in the presence of glycerol kinase (GK) ATP and Mg++ ions is
phosphorilated to glycerol-1-phosphate. This
latter metabolite is then oxidized by glycerophosphate oxidase (GPO) to produce
hydrogen peroxide. The hydrogen
peroxide thus produced is quantitatively determined by coupling
4-aminoantipyrine with N-ethyl-N-(2-hydroxy-3-sulphopropyl)-m-toluidine (TOOS) ,
where a quinonemine dye with maximum absorption at 550 nm is produced. TRIG is a one reagent chemistry available in three sizes. Reagents are
packaged in small glass bottles. Calibrator and controls are available
separately. TRIG C114-01 6x25 ML, TRIG C114-02 6x50 ML, TRIG C112-01, 4x500 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, triglycerides, TRIG, atherosclerosis, heart disease, diabetes mellitus,
nephritis, biliary obstruction, metabolic disorders For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3026a 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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