Related Experiment Video
Updated: Sep 27, 2026

07:27
The Development of Lyophilized Loop-mediated Isothermal Amplification Reagents for the Detection of Coxiella burnetii
Published on: April 18, 2016
Foreign Establishment Registration and United States agent requirements
Cynthia J M Nolte1, Mary McNamara-Cullinane
1Medical Device Consultants Inc., North Attleboro, Massachusetts, USA.
Abstract:
In 2002 the Food and Drug Administration implemented new requirements for foreign companies that import medical devices into the United States (US). This article reviews the Establishment Registration requirements and discusses the new Establishment Registration and US Agent requirements for non-US companies.
Related Concept Videos
Masking and Demasking Agents
EDTA titrations may necessitate masking and demasking agents to temporarily protect a particular metal ion in a mixture from the EDTA reaction. These agents facilitate the sequential analysis of the metal ions by forming stable complexes with some—but not all—metal ions during certain steps.
There are many masking agents, such as cyanide, fluoride, triethanolamine, thiourea, and 2,3-bis(sulfanyl)propan-1-ol (formerly 2,3-dimercapto-1-propanol), with the masking agent chosen based on the metal...
There are many masking agents, such as cyanide, fluoride, triethanolamine, thiourea, and 2,3-bis(sulfanyl)propan-1-ol (formerly 2,3-dimercapto-1-propanol), with the masking agent chosen based on the metal...
Nuclear Export
The nucleus restricts several proteins within and allows others to pass. The restricted proteins possess a nuclear retention sequence or NRS, anchoring them to the nuclear lamins and preventing their transport to the cytosol. The non-restricted proteins, after their synthesis, are transported to their site of action, such as the cytosol or other organelles, with the help of nuclear export signals or NES.
NES are of three types- the canonical 10-residue long leucine-rich signal and other...
NES are of three types- the canonical 10-residue long leucine-rich signal and other...
Enzyme-linked Receptors
Enzyme-linked receptors are proteins that act as both receptor and enzyme, activating multiple intracellular signals. This is a large group of receptors that include the receptor tyrosine kinase (RTK) family. Many growth factors and hormones bind to and activate the RTKs.Neurotrophin (NT) receptors are a family of RTKs, including trkA, trkB, and trkC (tropomyosin-related kinase) receptors. TrkA is specific for nerve growth factor (NGF), neurotrophin-6, and neurotrophin-7. TrkB binds...
Drug Dissolution: Requirements and Profile Comparison
The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
Relationship Formation
What do you think is the single most influential factor in determining with whom you become friends and whom you form romantic relationships? You might be surprised to learn that the answer is simple: the people with whom you have the most contact. This most important factor is proximity. You are more likely to be friends with people you have regular contact with. For example, there are decades of research that shows that you are more likely to become friends with people who live in your dorm,...
