Is iSTAT CLIA waived?

The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status.

How much does an iSTAT machine cost?

The Current Price Range Based on 15 Vendors on Bimedis. It’s Costs Starts Approximately at $1,300 and ends at the Highest Price $6,500. The Average Price for ABBOTT LABS I-STAT 1 – $3,690 Based on 48 Listings of This Product.

What does an iSTAT test?

The i-STAT is an in vitro whole-blood analyser that uses single-use cartridges for critical care tests at the point of care, such as blood gases, electrolytes, metabolites and coagulation.

Is the iSTAT Chem 8 CLIA-waived?

iSTAT CG8+ Cartridges NOTE: This product is not CLIA-waived; it is CLIA-classified as moderately complex. FDA-cleared for professional use only.

What does iSTAT stand for?

International Society of Transport Aircraft Trading.

How long are iSTAT cartridges good for?

i-STAT cartridges have a 14 day room temperature expiry except for CG8+, EG6+, CG4+ blood gas cartridges which have a 2 month room temperature expiry. Mark the cartridge box or cartridge pouches with the room temperature expiry date.

What is included in a chem8?

This panel includes Calcium (Total), Carbon Dioxide (CO2 Content), Chloride, Creatinine, Glucose, Potassium, Sodium, and Urea Nitrogen.

What is a Chem 8 panel?

A basic metabolic panel including calcium is sometimes colloquially referred to as a “CHEM-8”. Calcium, as an alkaline earth metal, is also an electrolyte, but abnormalities are more commonly associated with malnutrition, osteoporosis, or malignancy, especially of the thyroid.

Is a CBC a CLIA waived test?

The Food and Drug Administration (FDA) has granted premarket clearance and a CLIA waiver to Sysmex America for its complete blood cell count (CBC) test, the XW-100 Automated Hematology analyzer.