BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Neg MIC 3J REF C54814

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 1, 2026

    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter, Inc.·May 6, 2015

    Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024