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Bridgeport,
Connecticut, USA (April 14, 1987)…. Catachem, Inc. (Private) announced today
that it has received 510k clearance from the United States Food and Drug
Administration (FDA) for the Alkaline Phosphatase (ALP) in vitro diagnostic
chemistry reagent kit. Measurements of
Alkaline Phosphatase (ALP) are used primarily for diagnosing liver or bone
diseases, as well as for monitoring the causes and treatments.
ALP is an enzyme produced primarily in the liver and in bone. It is also
produced by the placenta of a pregnant woman and, to a lesser extent, by the
intestines and kidneys. The chemical structure of ALP produced by the liver is
slightly different from the structure of ALP produced by bone. If ALP levels in
the blood are high, further testing may be done to determine the cause of the
elevated ALP levels. Normally, the
liver produces more ALP than the other organs or the bones. Some conditions can
release large amounts of ALP into the bloodstream. These conditions include
rapid bone growth (during puberty), bone disease (osteomalacia or Paget’s
disease), or damaged liver cells. This
test is done on a blood sample taken from a vein.
Alkaline phosphatase catalyzes the conversion of p-nitrophenyl phosphate (PNPP)
to p-nitrophenol. P-nitrophenol is
a bright yellow-colored compound which has maximum absorbance at 405 nm.
The rate of increase in absorbance from p-nitrophenyl phosphate
(colorless) to p-nitrophenol (color) is directly proportional to the AP enzyme
activity in the serum sample. ALP is a two reagent chemistry kits are available in
two sizes, reagents are available separately.
Reagents are packaged in small glass bottles. Calibrator and controls are
available separately. ALP Kit C174-0A 750 tests, ALP Kit C174-0B 1500 tests, ALP
Reagents: ALP R1 C172-01 4x500 ML, ALP R2 C172-02 6x21g. 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, Alkaline Phosphatase,
ALP, osteomalacia or Paget’s disease
For
more information contact: Benjamin Twombly Catachem, Inc. 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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