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Bridgeport,
Connecticut, USA (June
29, 1989)….
Catachem, Inc. (Private) announced today that it has received 510k clearance
from the United States Food and Drug Administration (FDA) for the Calcium Arsenazo
(CA3) in
vitro diagnostic chemistry reagent kit. Measurements of
Calcium (CA) activator are primarily used for diagnosing hyperparathyroidism,
steatorrhea, nephrosis, nephritis and pancreatitis, as well as for monitoring
the causes and treatments. Calcium
is the most plentiful mineral in the body and one of the most important. The
body needs it to build and repair bones and teeth, help nerves function, make
muscles contract, clot blood, and allow proper function of the heart. Almost all
of the calcium in the body is stored in bone. The rest is found in the blood.
Getting enough calcium (at least 1 gram a day) in the diet is important,
since the body loses calcium every day. The main sources of calcium are dairy
products (milk, cheese), eggs, fish, green vegetables, and fruit.
Under normal conditions, the level of calcium in the blood is carefully
controlled. When blood calcium levels fall, calcium is released from bones to
restore proper blood levels. When blood calcium levels rise, the excess calcium
may be stored in bone or passed out of the body in urine and stool. This control
depends upon: The amount of calcium in the diet. The amount of calcium and
vitamin D absorbed by the intestines. The amount of phosphate in the body. The
production of certain hormones, including parathyroid hormone, calcitonin, and
estrogen. Vitamin D and certain
hormones (such as parathyroid hormone and calcitonin) help control the total
amount of calcium in the body. They also regulate the amount of calcium absorbed
from food and the amount removed from the body by the kidneys. The blood levels
of phosphate are closely linked to calcium levels. They usually work in opposite
directions: as blood calcium levels rise, phosphate levels fall.
Most people who have abnormal blood calcium levels do not have any
symptoms. Usually, calcium levels need to be extremely high or low to cause
symptoms. This test is done on a
blood sample taken from a vein. Total free calcium in serum reacts at 25 degrees C
with Arsenazo-III at pH 6.5 to form a purple-colored complex with maximum
absorbance at 650 nm. The increase
of the purple-colored complex is directly proportional to the concentration of
calcium in the sample. CA3 is a one reagent
chemistry available in four sizes. Reagents
are packaged ready-to-use in small glass bottles. Calibrator and controls are
available separately: CA3 C294-05 1x500 ML, CA3 C294-06, 1x500 ML, CA3 C292-03
4x500 ML, CA3 C292-04 6x1000 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, Calcium Asrenazo, CA3 For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3111a 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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