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 (October
23, 1987)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the Inorganic Phosphorous (Phosphate, Inorganic Phosphate, IP, P, PO4)
in
vitro diagnostic chemistry reagent kit. Measurements of
Inorganic Phosphates (IP) are primarily used for diagnosing hyper vitaminosis D,
hypoparathyroidism, renal failure, rickets and Fanconi syndrome, as well as for
monitoring the causes and treatments. Phosphate
is an electrolyte that carries an electrical charge when dissolved in blood.
Most of the body's phosphate (about 85%) is found in bones. The rest of it is
stored in tissues throughout the body. Phosphate
is needed for bone growth, energy, fighting infection, and proper muscle
function. Phosphate and calcium levels are regulated by a hormone called
parathyroid hormone (PTH). The amount of phosphate in the blood affects the
level of calcium in the blood. For this reason, phosphate and calcium levels are
usually measured at the same time. The kidneys help control the amount of
phosphate in the blood. If there is too much phosphate, the kidneys pass the
excess in the urine. If there is not enough phosphate, the kidneys reduce the
amount passed in the urine. An abnormally high level of phosphate in the blood
is usually due to a kidney problem that prevents the excess from being passed
into the urine. Phosphate is found
in foods such as cereal, dairy products (such as milk and cheese), eggs, and
meat. Adequate amounts of vitamin D are needed to help the body absorb phosphate
and calcium. This test is done on a
blood sample taken from a vein. P,
PO4, Phosphate, Inorganic Phosphate, Inorganic Phosphorus. Phosphorus from the serum sample mixes with the
molybdate to form the phosphomolybdate complex. The increase in absorbance is monitored at 340 nm. IP is available as a one reagent AND a two reagent chemistry.
The one reagent kit is available in one size.
Reagents are available separately for the two reagent chemistry.
Reagents are packaged ready-to-use in small glass bottles. Calibrator and
controls are available separately. IP
Kit (1 reagent) C274-01 1x500 ML 1667 tests, IP R1 (2 reagent) C272-01 4x500 ML,
IP R2 (2 reagent) C272-02 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, Inorganic Phosphorous, Phosphate, Inorganic Phosphate, IP, P, PO4, hyper
vitaminosis D, hypoparathyroidism, renal failure, rickets, Fanconi syndrome For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3022a 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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