Laboratories need to follow all CLIA regulations that apply to moderate complexity testing. (124 pages) Blood Glucose Meter Abbott FreeStyle Precision Neo User Manual. 604990 MF ID 04J5101 Brand iSTAT Ceramic Manufacturer Abbott Point of Care Application Cartridge For Use With For i-STAT Handheld Blood Analyzer Product. For use with a clia certificate of waiver (7 pages) Blood Glucose Meter Abbott FreeStyle Libre User Manual.
#Abbott istat registration
Laboratories with a Certificate of Registration that applied for a Certificate of Compliance, or laboratories with a Certificate of Compliance, that have the i-STAT system, will continue to be allowed to use the cTnI test cartridge as a moderate complexity test.Įnforcement discretion will continue for the duration of the declared COVID-19 public health emergency or until the FDA has cleared/approved the changes to this test cartridge, whichever comes first. Handhelds Abbott i-STAT 1 Quick Reference Manual.
In response to the release of the November 2022 Abbott Point of Care customer letter (11-2022-168), which stated that the current version of the i-STAT cTnI cartridge is not FDA-cleared due to changes made to the product since 2003, the Centers for Medicare and Medicaid Services is exercising enforcement discretion (as of ). The i-STAT 1 Wireless is a portable, handheld blood analyzer capable of tansmitting test results wirelessly to ILS or EMR Compatible with 802.11b/802.11g.
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