Histo/Pathology
Packaging Testing
In Vitro Biocompatibility
HCT/P
Analytical Testing
100
This cutting system is used to process hard implants while maintaining intimate contact with surrounding tissue, and can perform routine high-quality processing of soft implants in hard tissue without decalcification.
What is Exakt® Histological System
100
The process in which packaging systems for medical devices are shown to maintain sterility until the point of use
What is Package Validation
100
This is the expected cytotoxicity outcome of a medical device made of or coated with silver
What is failure. A medical devide containing or coated with silver is expected to result in a failure for cytotoxicity. This in known and generally described in the results.
100
What is the term for restoring the body via cell therapy and tissue engineering
What is Regenerative Medicine
100
Particulate testing and USP <788> is conducted in this facility
What is Irvine
200
This material is used for tissue embedding due to its capability to convert from a liquid to solid form.
What is a paraffin
200
Storage at elevated temperatures/ intensified environmental conditions in order to simulate real time aging
What is Accelerated Aging
200
With sales of approximately $2.2 million in 2014, this cytoxicity assay is the top selling in vitro test code by volume and sales dollars?
What is V0014-130 (ISO Elution Method)
200
The regulatory guidance for minimally manipulated tissue is
What is 361
200
Chemical characterization or extractables testing is cited in this standard
What is ISO 10993-18
300
This is the significance of 50,000
What is the number of slides processed in the Northwood Histology Lab in FY2014
300
ASTM D3078 Vacuum Leak Test and ASTM F2096 Gross Leak Test
What is Bubble Emission Package Integrity Tests
300
These NAMSA facilities perform in vitro testing?
What is Irvine, Northwood and Lyon
300
This is an implantable processed from human cells and tissue
What is an Allograft
300
Often abbreviated as UPLC/MS it is more formally known as this
What is Ultra High Performance Liquid Chromatography/ Mass Spectroscopy
400
If I have an Irritant Ranking Score of 8.7 for a standard ISO Muscle or Subcutaneous Implantation program, this is scored as a ______ Irritant (Non, Slight, Moderate or Severe)
What is Slight
400
The main harmonized standard that regulates packaging for terminally sterilized medical devices
What is ISO 11607 (Parts 1 &2)
400
This is the ASTM standard that NAMSA performs hemolysis test under?
What is ASTM F756
400
A commercially available recombinant BMP product
What is Infuse
400
This instrument produces a "fingerprint" spectrum of common polymeric surfaces or extractables and is conducted in both the CA and OH facilities
What is Fourier Transform Infrared Analysis (FTIR)
500
Spell out the stain we routinely use for tissue evaluation
What is Hematoxylin & Eosin (H&E)
500
The transport testing standard NOT currently recognized by the FDA but currently working with FDA to be recognized
What is ISTA Standards (International Safe Transit Association)
500
The Mouse Lymphoma assay utilizes L5178Y/TK cell line. What does the TK stand for?
What is Thymidine Kinase
500
An implantable product utilizing a patient's own cells or tissue
What is Autologous
500
These three main aspects of a device are required for developing a chemical characterization program
What is device use and contact; device composition; purpose for testing
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