FDA Classifications

1 NSH Contact Hour(s)
Eligible members save $5. If you're a member, enter your member number here to get the member price »

Traci DeGeer, HTL(ASCP)QIHC

In the ever-changing fields of immunohistochemistry and molecular diagnostics, it has become increasingly important to understand the regulatory implications of the assays we bring into the laboratory. To do this, we must explore how the FDA views classifications that appear in the specification sheets supplied by manufacturers. The purpose of this presentation is to help gain an understanding of those FDA classifications as they apply to these specification sheets from a laboratory perspective and manufacturing perspective.

See more courses in: Management/Laboratory Operations

Included In These Course Packages

Continuing Education Credits

NSH Contact Hours (acceptable for AMT, ASCP, and state recertification): 1 hour(s)
Course number IHC071117
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)
Florida Board of Clinical Laboratory Personnel Credit Hours - General (Clinical Chemistry/UA/Toxicology): 0 hour(s)
Course number 20-648646, approved through 8/1/2019

Objectives

  • Describe the levels of classification
  • Differentiate between an RUO and ASR
  • Recognize a what is meant by Class I, II and III in relation to FDA designation

Users Also Bought

Additional Information

Course Overview: In the ever-changing fields of immunohistochemistry and molecular diagnostics, it has become increasingly important to understand the regulatory implications of the assays we bring into the laboratory. To do this, we must explore how the FDA views classifications that appear in the specification sheets supplied by manufacturers. The purpose of this presentation is to help gain an understanding of those FDA classifications as they apply to these specification sheets from a laboratory perspective and manufacturing perspective.
 
Presenter Bio: 
Traci DeGeer serves the Global Innvation and Product Manager-BOND RX with Leica Biosystems. Prior to her current role, Ms. DeGeer was the Discovery Training Manager for Roche Molecular Systems where she developed training programs for researchers and Roche training sites world wide. Traci received her bachelors of science in Biology from Radford University in Virginia. She is certified both as a HT and a HTL and has her QIHC. At the start of her career she worked in the clinical setting as a Histotechnologist, Lead Histotechnologist. She then moved to Ventana Medical Systems in 2004 as a technical customer care executive and 8 months later into training.  Traci has performed numerous workshops at both the state and national level on a variety of different topics. Traci is an active member of the NSH where she serves as chair of the Education and CEU committees.
 
Additional Information: This course was presented July 2017 as part of the IHC Webinar Series.  

How to Subscribe
IHC Webinar Series
Package of 5 online courses$120
NSH members save $20
Add to cart
Single online course$30
Eligible members save $5
Add to cart
  • Order for instant access through any computer, any browser.
  • No shipping, faxing, or waiting for certificates.
  • Print or save your certificate of completion as soon as you've completed the course.
  • You'll have a full year (365 days) to complete your purchased courses.
FDA Image



 
Learn.NSH.org's design and platform are provided by MediaLab, Inc.