Acronym Antics
FDA
what is the acronym for food and Drug Administration
Chemical Entities without a tentative or confirmed identity.
What are unknowns?
Water is this type of solvent
what is a polar solvent
this is body temperature in celsius
what is 37 C
MDR
What is the acronym for Medical device Regulatioin
the amount of testing article needed for chemistry testing to be conducted
What is sample requirements?
Hexane is this type of solvent
what is a non polar solvent
The testing portal utilized by customers in Obernburg and Lyon
What is NAMSA 360
GCMS
What is the acronym for Gas Chromatography Mass Spectometry
the term commonly used by NAMSA indicating the point in time when tat starts for testing
What is login?
This is a common temperature used for the exhaustive extraction of metals in hexane
what is 50 degrees celsius
these are the 2 cities where NAMSA has chemical characterization laboratories
what are Toledo/Northwood and Obernburg
ICP
What is the acronym for Inductively Coupled Plasma
a statement received from a regulatory agency such as the FDA listing problems with the submission
what is a deficiency?
the name of the threshold at or above which a chemist should begin to identify a particular leachable and/or extractable and report it for potential toxicological assessment.
What is AET or analytical evaluation threshold?
this is the year NAMSA was founded
what is 1967
LCMS
what is the acronym for
Liquid chromatography–mass spectrometry
this is one of the differentiation characteristics listed in the namsa playbook for chemical characterization
the Annex where one finds the discussion of toxicological equivalency in 10993-18
What is Annex C?
this term is utilized to address the overall biocompatibility of a medical device
what is biological safety?