|
||
| |||||||
|
Bridgeport,
Connecticut, USA (April
10, 1989)….
Catachem, Inc. (Private) announced today that it has received 510k clearance
from the United States Food and Drug Administration (FDA) for the Total
Bilirubin (TBILI) in
vitro diagnostic chemistry reagent kit. Measurements of Total Bilirubin (TBILI) in blood are used for diagnosing
obstructive jaundice and hepatitis, as well as to monitor the causes and
treatment. Total bilirubin levels
are elevated in babies with jaundice. Total bilirubin (direct bilirubin plus
indirect bilirubin) is often measured by itself. If the total bilirubin result
is abnormally high, the direct and indirect forms of bilirubin are then usually
measured separately to provide more information. Bilirubin
is a brownish yellow substance found in bile. Bilirubin is produced when the
liver breaks down hemoglobin, the oxygen-carrying substance in red blood cells.
Bilirubin is then removed from the body through the stool (feces) and gives
stool its normal brown color. Bilirubin circulates in the bloodstream in
two forms: Indirect (or unconjugated)
bilirubin. This form of bilirubin does not dissolve in water (it is
insoluble). Indirect bilirubin travels through the bloodstream to the liver,
where it is changed into a soluble form. Direct (or conjugated) bilirubin. After indirect bilirubin has been
changed by the liver into a form that dissolves in water (soluble), it is called
direct or conjugated bilirubin. Total bilirubin and direct bilirubin levels are
measured directly in the blood, whereas indirect bilirubin levels are derived
from the total and direct bilirubin measurements.
The most obvious symptom of high bilirubin levels is jaundice, a
condition in which the skin and whites of the eyes appear yellow. Jaundice is
caused by the buildup of bilirubin in the blood and skin from liver disease
(hepatitis), blood disorders (haemolytic anemia), or blockage of the tubes (bile
ducts) that allow bile to pass from the liver to the small intestine.
Excessive buildup of bilirubin in a newborn baby sometimes causes brain
damage and even death. Therefore, some babies who develop jaundice may be
treated with special lights or a blood transfusion to reduce their bilirubin
levels. This test is done on a
blood sample taken from a vein. In a newborn baby, the blood sample is usually
taken from the heel (heel stick). Bilirubin from the serum sample mixes with diazotized sulfanilic acid to
form an azo-bilirubin complex. The
increase in absorbance is monitored at 550 nm. TBILIB is a two
reagent chemistry and kits are available for R2 and reagents are available for
R1 separately. Reagents are
packaged in small glass bottles. Calibrator and controls are available
separately. TBILIB R2 Kit
C314-0B 530
tests, TBILIB Reagent: TBILIB R1 C314-04 1x500 ML. 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, Total Bilirubin, TBILI,
haemolytic anemia, hepatitis For
more information contact: Benjamin
Twombly Catachem,
Inc. Ref:
C3108a 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. |
|
| ||||||||