VITEK 2

REF # (Description): 418114 (AST-GN94), 22258 (AST-N102), 412605 (AST-N194), 412921 (AST-N199), 412862 (AST-N201), 412863 (AST-N202), 412924 (AST-N205), 412918 (AST-N210), 413061 (AST-N212), 413083 (AST-N222), 413112 (AST-N225), 413171 (AST-N236), 413172 (AST-N237), 413204 (AST-N239), 413205 (AST-N240), 413391 (AST-N242), 413394 (AST-N245), 413397 (AST-N248), 413572 (AST-N249), 413722 (AST-N253), 413724 (AST-N255), 413725 (AST-N256), 413753 (AST-N261), 414164 (AST-N272), 414286 (AST-N276), 414492 (AST-N279), 414531 (AST-N280), 414532 (AST-N281), 414972 (AST-N288), 415063 (AST-N292), 415369 (AST-N293), 415433 (AST-N295), 416005 (AST-N299), 416241 (AST-N300), 416590 (AST-N303), 416913 (AST-N308), 416914 (AST-N309), 417426 (AST-N315), 417952 (AST-N318), 418204 (AST-N320), 418489 (AST-N322), 418513 (AST-N235), 418514 (AST-N326), 418630 (AST-N328), 418631 (AST-N329), 418675 (AST-N331), 418676 (AST-N332), 418985 (AST-N335), 419077 (AST-N338), 419341 (AST-N339), 420063 (AST-N343), 420440 (AST-N344), 420867 (AST-N347), 420856 (AST-N348), 421258 (AST-N352), 421297 (AST-N353), 421350 (AST-N354), 421351 (AST-N355, 421451 (AST-N357), 421441 (AST-N358), 421583 (AST-N360), 421584 (AST-N361), 421585 (AST-N362), 421692 (AST-363), 421693 (AST-N364), 421830 (AST-N365), 421853 (AST-N366), 421854 (AST-N367), 421855 (AST-N368), 410025 (AST-XN01), 413230 (AST-XN05)

Immunology and Microbiology Devices

2

No

Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.

VITEK 2 Gram Negative test kits containing colistin (cs01n)

VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.

Immunology and Microbiology Devices

2

No

Worldwide

VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.

Immunology and Microbiology Devices

2

No

Worldwide

VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018

Immunology and Microbiology Devices

1

No

US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom

VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. || VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria