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Bridgeport,
Connecticut, USA (June 26, 1989)….
Catachem, Inc. (Catachem, Private) announced today that it has received 510k
clearance from the United States Food and Drug Administration (FDA) for the Creatinine (CREAT) in
vitro diagnostic chemistry reagent kit. Measurement of
Creatinine (CREAT) are primarily used for diagnosing chronic hemorrhagic
nephritis and impairment of kidney function, as well as for monitoring the
causes and treatments. Creatine is a substance that forms when food is converted
into energy through a process called metabolism. Creatine is broken down into
another substance called creatinine, which is filtered out of the blood
by the kidneys and then passed out of the body in urine. Creatinine is produced
at a steady rate and is affected very little by diet or by normal physical
activities. If the kidneys are damaged and cannot function normally, the amount
of creatinine in the urine decreases while its level in the blood increases.
Creatinine levels provide information about how well the kidneys are
working. Three types of tests involving creatinine can be done: a blood
creatinine level, a creatinine clearance test, and a blood test that measures
both creatinine and blood urea nitrogen (BUN) levels. These tests are done on a
sample of blood taken from a vein. Creatinine present in the serum sample reacts at 37° C with picric acid in
alkaline solution to produce a red tautomer complex which has a maximum
absorption at 505 nm. CREA is a two reagent chemistry, reagents are
available separately in two sizes. Reagents
are packaged in small glass bottles. Calibrator and controls are available
separately. CREA R1 C324-01 1x250 ML, CREA R2 C324-02 1x250 ML, CREA R1 C322-01
4x500 ML, CREA R2 C322-02 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, Creatinine, CREAT, chronic hemorrhagic nephritis, kidney function For
more information contact: Benjamin Twombly Ref: C3031a 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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