Portable Blood Analyzer System Abbott i-STAT 200 Portable Clinical Blood Analyzer Kit includes: Analyzer. Inserting one of the several testing cartridges, and then viewing test results: The sysĪbbott I-Stat 200 w/ Printer. Making it completely portable features ergonomically designed soft keys for comfort and ease of use, Patient-side testing is as easy as entering the operator and patient information into the handheld. The portable i-STAT 1 handheld makes patient-side testing easy: Requires no special sample preparation or user calibration maintenance is minimal weighs 18 ounces. All other i-STAT cartridges are categorized as moderate complexity. For the purpose of CLIA compliance, the i-STAT CHEM8+ cartridge is categorized as Waived. Cartridges, and test strips should be used by healthcare professionals trained and certified to use the system and should be used according to the facility’s policies and procedures. The i-STAT 1 Analyzer is intended for use with i-STAT cartridges for in vitro quantification of various analytes in whole blood and with the Abbott MediSense Precision PCx Blood Glucose Test Strip for the in vitro quantification of glucose in whole blood. Electrolytes, chemistries, coagulation, haematology, glucose and cardiac markers.
Carrying Case& Accessories As Listed Above! Working Condition: Excellent Condition: Refurbished Calibrated: Yes Warranty: 90 Day Exchange Warranty The Abbott i-STAT® 1 is a revolutionary handheld analyzer that provides labaccurate test results in minutes for a range of measurements including blood gases.
ABBOTT CLEW MANUAL
more AC Adapter/Charger Power Cord RS232 PC Interface Cable User Manual On CD-ROM Carrying Case(G) BE SURE TO CHECK OUR EBAY STORE FOR OTHER ITEMS! Abbott Heska i-STAT1 300 Handheld Clinical Analyzer No Testing Cartridges Included In Sale! Use the i-STAT1 with i-STAT cartridges to test blood gases.
ABBOTT CLEW SOFTWARE
Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 585KB).See the links on the left side of this page to find monthly listings of 510(k)s cleared by FDA. Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
This is known as Premarket Notification - also called PMN or 510(k). Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.
0 kommentar(er)
