Is Istat CLIA-waived?
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status.
What is an Istat procedure?
When a sample-filled i-STAT cartridge is inserted into the i-STAT 1 handheld for analysis, the handheld automatically controls all functions of the testing cycle, including fluid movement within the cartridge, calibration, and continuous quality monitoring.
When the Istat displays a code 14 what step should be taken next?
If code 14 reoccurs, contact i-STAT Technical Services or your local support organization for further assistance. 15 Barcode Does Not Match Cartridge Type The barcode scanned by the user does not match the immunoassay cartridge type indicated by the identification chip in the cartridge.
What is the purpose of the electronic simulator Istat?
While the analyzer performs internal electronic checks and calibration during each testing cycle, the electronic simulator test provides an independent check on the ability of the analyzer to take accurate and sensitive measurements of voltage, current, and resistance from the cartridge.
What tests are considered CLIA-waived?
CLIA Waived Drug Tests These are simple tests with a low risk for erroneous results. Drug test dip cards and drug test cups are considered CLIA Waived tests. Sites that only perform waived testing require a CLIA certification. The CLIA has granted waived status to over 200,000 laboratories across the United States.
How accurate is an i-STAT?
Furthermore, the Sysmex XE-2100™ has been evaluated to be an accurate and precise analyser with a CV between 0 to 3.9% and r2 of 1.019. T=0 is prior to blood loss; T=1 is after 25% blood loss.
What is the amount of time required for the analyzer to conduct a test i-STAT?
Fast, lab-quality results Provides accurate results in approximately 2 minutes for most tests.
Where can I find the i-STAT user manual?
Printed in USA. i-STAT is a registered trademark of the Art: 726064-00J Rev. Date: 13-Feb-17 Abbott Group of Companies in various jurisdictions. Appendix 1: i-STAT 1 Wireless Analyzer Labels System Components Note: Pictured below are the three different labels that the i-STAT 1 Wireless Analyzer may have.
What is the purpose of the i STAT 1 wireless analyzer?
System Components 2 19 Intended Use: The i-STAT 1 Wireless Analyzer is intended for use, together with i-STAT Cartridges, by trained medical professionals. Note: UL CertiRcation UL File Number E470709 covers the i-STAT 1 Wireless Analyzer and the Electronic Simulator only.
What is the FCC ID for an i-STAT analyzer?
Analyzers whose label contains two blue triangles, one in each of the upper corners, are referred to as having Wireless Module FCC ID: YOPGS1500M without SHA-256 support (Firmware: GEXPSX.X.X/MCUX.X).
What is the UL file number for i-STAT 1?
Note: UL CertiRcation UL File Number E470709 covers the i-STAT 1 Wireless Analyzer and the Electronic Simulator only. Appendix 1: i-STAT 1 Wireless Analyzer Labels