ABS2000 News Releases Archive
03/18/96 Immucor Files 510(k) for ABS2000
NORCROSS, Ga., March 18 /PRNewswire/ -- Immucor, Inc. (Nasdaq: BLUD), maker of blood bank reagent systems and related products, announced today it has filed an application with the U.S. Food and Drug Administration for clearance of the Company's automated analyzer for the blood bank laboratory, the ABS2000.
During recently completed clinical trials at several transfusion service laboratories -- including university hospitals, a donor center/centralized transfusion service, a reference laboratory and a community hospital -- patient and donor blood samples were tested for transfusion compatibility using currently approved manual methods and techniques. The samples were tested in parallel using Immucor's ABS2000 automated analyzer to establish equivalency
of results.
Commenting on the FDA submission, Edward L. Gallup, President of Immucor, Inc. said, "based upon the comparative test results obtained during the clinicals, we filed our 510(k) application with FDA. We intend to request FDA clearance to export the ABS2000 to certain non- U.S. markets as an unapproved medical device. When clearance is received, we will be able to export the ABS2000 to those markets while FDA reviews our U.S. application for domestic
market clearance."
The ABS2000 is the first fully-automated, or "walk-away," medical laboratory analyzer to perform the routine blood transfusion compatibility tests currently done manually by blood bank technologists.
Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used primarily by hospitals and donor centers in a number of tests performed to detect and identify certain properties of the cell and serum components of blood prior to transfusion.
CO: Immucor, Inc.
ST: Georgia
IN: MTC
03/18/96 Immucor Files FDA Application for ABS2000
NORCROSS, Ga., March 18 (Reuter) - Immucor Inc said on Monday that it has filed an application with the U.S. Food and Drug Administration for clearance of its automated analyzer for the blood bank laboratory.
Immucor said that the analyzer is the first fully-automated, or "walk-away," medical laboratory analyzer to perform the routine blood transfusion compatibility tests currently done manually by blood bank technologists.
09:11 03-18-96
01/06/97 Immucor Responds to FDA on ABS2000
NORCROSS, Ga., Jan. 6 /PRNewswire/ -- Immucor, Inc. (Nasdaq: BLUD), maker of blood bank reagent systems and related products, announced today it has responded to the US Food and Drug Administration (FDA) questions and comments concerning the Company's 510(k) application for market clearance of the ABS2000.
Commenting on the Company's FDA response, Edward L. Gallup, President of Immucor, Inc. said, "It's customary to receive questions and comments during the FDA review process, and they were received on December 4, 1996." Mr. Gallup also noted, "The Company received questions and comments addressing the instrument, software, and the Company's reagent products used to run the ABS2000. As directed by the FDA, the Company answered questions and comments within a 30 day time period. The next step in the FDA clearance process is to await additional questions, comments or requests for clarification of our responses, if any."
Capitalizing on its patented and proprietary Capture(R) product technology, Immucor developed the ABS2000 to automate certain labor intensive, time consuming blood transfusion compatibility tests currently performed manually by laboratory technologists. On March 18, 1996, following extensive clinical trials, the Company filed its application with FDA for market clearance.
Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used primarily by hospitals and donor centers in a number of tests performed to detect and identify certain properties of the cell and serum components of blood prior to transfusion.
SOURCE Immucor, Inc.
-0- 01/06/97
/CONTACT: Richard J. Still, Senior Vice President-Finance, Immucor, Inc.,
770-441-2051/
(BLUD)
CO: Immucor, Inc.
ST: Georgia
IN: MTC
SU:
09/22/97 Immucor Responds to FDA on Second Round of ABS2000 Questions
NORCROSS, Ga., Sept. 22 /PRNewswire/ -- Immucor, Inc. (Nasdaq: BLUD), maker of blood bank reagent systems and related products, announced today it has responded to the US Food and Drug Administration (FDA) questions and comments concerning the Company's 510(k) application for market clearance of
the ABS2000.
Commenting on the Company's FDA response, Edward L. Gallup, President of Immucor, Inc. said, "The Company received questions and comments addressing the instrument, software, and the Company's reagent products used to run the ABS2000. As directed by the FDA, the Company answered questions and comments within a 30 day time period."
Capitalizing on its patented and proprietary Capture(R) product technology, Immucor developed the ABS2000 to automate certain labor intensive, time consuming blood transfusion compatibility tests currently performed manually by laboratory technologists. On March 18, 1996, following extensive clinical trials, the Company filed its application with FDA for market clearance.
Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used primarily by hospitals and donor centers in a number of tests performed to detect and identify certain properties of the cell and serum components of blood prior to transfusion.
SOURCE Immucor, Inc.
-0- 09/22/97
/CONTACT: Connie Vinson, Immucor Corporate Communications, 770-441-2051/
(BLUD)
CO: Immucor, Inc.
ST: Georgia
IN: MTC
|
