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Which iSTAT cartridges are waived?

Which iSTAT cartridges are waived?

The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA …

Do iSTAT cartridges need to be refrigerated?

Cartridges may be stored at room temperature (18 to 30°C or 64 to 86°F) for 14 days. Cartridges should not be returned to the refrigerator once they have been at room temperature, and should not be exposed to temperatures above 30°C (86°F). If the pouch has been punctured, the cartridge should not be used.

What is i-stat CG8+?

The i-STAT CG8+ is a blood gas panel plus electrolytes including glucose and ionized calcium measurements. Results can be obtained in two minutes without leaving the patient’s side, driving high quality, efficient and cost-effective care.

How long are i-STAT 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.

How accurate is i-STAT?

The i-STAT® manufacturer also recommends “haematocrit adjusting” using total plasma protein level to adjust the i-STAT®- measured Hct. This resulted in acceptably accurate Hct measurement (mean 0.53% with 1.46% standard deviation).

Is Istat FDA approved?

April 22, 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance. The i-Stat CG4+ cartridge with the i-Stat 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point-of-care or clinical laboratory settings.

How long are Istat cartridges good for at room temperature?

How long do the cartridges need to sit at room temperature before you can use them?

All cartridges should stand at room temperature for 1 hour before use (an entire box). Individual cartridges can be used after standing just 5 minutes at room temperature. § Verify that the cartridges stored in the refrigerator are all within the expiration date printed on the boxes.

How accurate is Istat?

How does the I-stat work?

Description. The i‑STAT is a handheld, in vitro analyser designed to be used at the patient’s bedside (point‑of‑care) for testing arterial, venous or capillary whole blood. It takes single‑use cartridges containing chemically sensitive biosensors on a silicon chip that are configured for test‑specific indicators.

What does an i-STAT test cartridge do?

The advanced i-STAT cartridge technology streamlines traditional lab technology, yet contains many of the components found in complex lab testing systems. Each test cartridge contains chemically sensitive biosensors on a silicon chip that are configured to perform specific tests.

How does a blood test work on an i-STAT?

To perform a test, 2 to 3 drops of blood are applied to a cartridge, which is then inserted into the i-STAT handheld. Prior to running a test, each cartridge initiates a series of preset quality control diagnostics, from monitoring the quality of the sample to validating the reagent.

Do you need a CLIA number to exchange an i-STAT cartridge?

NO RETURNS, REFUNDS, or EXCHANGES ARE ACCEPTED AFTER ORDER IS PLACED BY PHONE OR ONLINE. I must provide a valid CLIA License number in order to purchase the item. The advanced i-STAT cartridge technology streamlines traditional lab technology, yet contains many of the components found in complex lab testing systems.

How long does a CLIA Wai cartridge last?

NOTE: This product is not CLIA-waived; it is CLIA-classified as moderately complex. FDA-cleared for professional use only. All cartridges from CLIAwaived.com have a 60 day shelf life or longer. PLEASE ALLOW 2 DAY LEAD TIME. REFRIGERATED-PLEASE SELECT NEXT-DAY AIR SHIPPING FOR PRODUCT STABILITY.

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