Friday December 05 2008 | Biotechnology feed | All feeds
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Friday December 05 2008 | Biotechnology feed | All feeds
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Bridgeport,
Connecticut, USA (July 20, 1990)…. Catachem, Inc. (Catachem, Private)
announced today that it has received 510k clearance from the United States Food
and Drug Administration (FDA) for the Magnesium (MG) in vitro diagnostic chemistry reagent kit. Magnesium
(MG) is an important electrolyte needed for proper muscle, nerve, and enzyme
function. It also helps regulate energy production in cells and is needed to
move other electrolytes (potassium and sodium) into and out of cells. Magnesium
is one of the most abundant minerals in the body and is found mainly inside the
bones and cells. Only a tiny amount of magnesium is normally present in the
blood. It is absorbed through the small intestine during food digestion. A
balanced diet contains enough magnesium for the body's needs. Magnesium
deficiency is rare, but when it occurs it is often caused by conditions that
interfere with the ability of the intestines to absorb magnesium from food, by
poor diet, or by losing magnesium from prolonged vomiting or diarrhea. People
who have diabetes and those who drink excessive amounts of alcohol, overuse
diuretics, or have burns over a large area of their bodies are at high risk for
developing a magnesium deficiency. Symptoms of a magnesium deficiency include
weakness, dizziness, irregular heartbeat, tremors, and seizures. An increased
amount of magnesium in the blood can be caused by kidney failure or by excessive
use of certain medications that contain magnesium (such as antacids or
laxatives). Occasionally, an increased blood level of magnesium can be caused by
problems with the thyroid or parathyroid glands (such as hyperthyroidism or
hyperparathyroidism). Too much magnesium in the blood can cause low blood
pressure, nausea, vomiting, diarrhea, dizziness, and muscle weakness. Very high
levels of magnesium in the blood can lead to heart problems or an inability to
breathe, especially in people with kidney disease. This test is done on a blood
sample taken from a vein. Tests for other electrolytes, such as calcium,
potassium, sodium, and phosphorus, may be done along with a test for magnesium. MG is determined by mixing serum with the magnesium
reagent where the total magnesium ions react with the calmagite indicator to
form a pink magnesium-chelate complex with concomitant
reduction of the reagent absorbance which has a broad absorbance peak
between 600 and 650 nm. The decrease in absorbance is directly proportional to the
magnesium concentration in the sample. MG is a one reagent
chemistry available in two sizes. Reagents
are packaged ready-to-use in small glass bottles. Calibrator and controls are
available separately: MG C354-01 1x125 ML, MG C352-01 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, Magnesium, MG For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3028a 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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