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Bridgeport,
Connecticut, USA (August 19, 1987)…. Catachem, Inc. (Catachem, Private)
announced today that it has received 510k clearance from the United States Food
and Drug Administration (FDA) for the Gamma-Glutamyl Transferase (Gamma-glutamyl
transpeptidase, GGTP, GGT) in
vitro diagnostic chemistry reagent kit. Measurements of Gamma-Glutamyl
Transferase (GGT) activity are primarily used for diagnosing intra
or post hepatic biliary obstructions, metastatic neoplasm, drug intoxication,
chronic pancreatitis, we well as for monitoring the causes and treatments. GGT,
or gamma glutamyl transpeptidase, may be measured in the blood to distinguish
bone alkaline phosphatase (ALP) from liver ALP. High levels of GGT usually are
present when the liver is damaged but not present with bone disease. An
increased level of GGT may mean alcohol use or blocked bile ducts are causing
inflammation. The level of GGT also may increase with the use of certain
medications, such as dilantin and phenobarbital. Gamma-glutamyl transpeptidase,
Gamma-glutamyl transferase, GGTP or Gamma
glutamyltransferase transfers the gamma glutamyl group from the substrate gamma
glutamyl-p-nitroanilide (GNA) which has maximum absorbance at 405 nm.
The rate of increase in absorbance is directly proportional to the GGT
enzyme activity in the serum sample. GGT is a two reagent chemistry and kits are available in two sizes,
reagents are available separately. Reagents
are packaged in small glass bottles. Calibrator and controls are available
separately. GGT Kits: GGT Kit
C214-0A 500 tests, GGT Kit C214-0B 1000 tests, GGT Reagents: GGT R1 C212-01
4x500 ML, GGT R2 C212-02 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, Gamma-glutamyl
transferase, gamma-glutamyl transpeptidase, GGTP, GGT,
post hepatic biliary obstructions, metastatic neoplasm, drug
intoxication, chronic pancreatitis For
more information contact: Benjamin Twombly Catachem, Inc. Ref: C3030a 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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