Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Immucor ABS 2000 automated blood bank system clinical trials under way.

This article was originally published in The Gray Sheet

Executive Summary

IMMUCOR ABS 2000 AUTOMATED BLOOD BANK SYSTEM 510(K) SUBMISSION planned following completion of clinical trials, which are expected to take approximately four to six months, the Norcross, Georgia firm says. Trials for the device, used to perform ABO/Rh blood grouping, antibody screening and patient crossmatching, began the week of Sept. 4 at five blood bank transfusion service laboratories. The five labs include three university hospitals, a smaller, non-university hospital, and one donor/transfusion service lab. Trials at two other primary care facilities are expected to commence in the next few weeks.

You may also be interested in...



Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.

UsernamePublicRestriction

Register

MT004667

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel