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Bridgeport,
Connecticut, USA (January
24, 1995)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the
Chloride [340 nm] (CL) in
vitro diagnostic chemistry reagent kit. Measurements of
Chloride (CL) are primarily used for diagnosing chronic pyelonephritis,
metabolic acidosis, dehydration, congestive heart failure and hypercalcemia, as
well as for monitoring the causes and treatments.
Chloride is one of the most important electrolytes in the blood, along
with sodium, potassium, and calcium. Chloride helps keep the amount of fluid
inside and outside of cells in balance. It also helps maintain proper blood
volume, blood pressure, and pH of body fluids.
Most of the chloride in the body comes from table salt (sodium chloride)
in the diet. Chloride is absorbed by the intestines during food digestion. Any
excess chloride is passed out of the body through the urine. Chloride levels in
the blood generally rise and fall along with sodium levels in the blood.
The amount of chloride in the blood is indirectly regulated by the
hormone aldosterone, which also regulates the amount of sodium in the blood (see
the medical test Aldosterone). When the amount of sodium in the blood decreases,
the amount of chloride decreases as well, and vice versa. The level of chloride
in the blood is also related to the level of bicarbonate (see the medical test
Bicarbonate). When the amount of bicarbonate decreases, the amount of chloride
normally increases, and vice versa. A
test for chloride is usually done on a blood sample taken from a vein. Tests for
sodium, potassium, and bicarbonate are usually done at the same time as a blood
test for chloride. Occasionally, a test for chloride can be done on a sample of
all the urine collected over a 24 hour period (called a 24-hour urine sample) to
evaluate how much chloride is being released into the urine. Chloride ions present in the serum sample interact
with Ferric ions in dilute acid to form a yellow chloro-complex with maximum
absorption at 340 nm. The intensity
of the color thus produced is directly proportinal to the concentration of the
chloride ion in the serum sample. CL is a two reagent chemistry available in two sizes. Reagents are
packaged ready-to-use in small glass bottles. Calibrator and controls are
available separately. CL R1 C194-02 1x250 ML, CL R2 C194-03
1x500 ML, CL R1 C192-02 4x500 ML, CL R2 C192-03 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, Chloride, CL, for diagnosing chronic pyelonephritis, metabolic acidosis, dehydration,
congestive heart failure, hypercalcemia For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3027a 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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