ClearanceBrief
Panels › Microbiology › Product code LON · Class 2

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Regulation 866.1645

4510(k)s in 12 months (291 all time)
6recalls in 12 months (240 all time)
161recalls that name a 510(k)
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Top companies in LON

DateFirm and productCodeLinked 510(k)
Oct 9, 2026Becton Dickinson & Co.
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Open, Classified
LONK181665
Oct 9, 2026Becton Dickinson & Co.
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Open, Classified
LONK181665
Sep 18, 2026Biomerieux Inc
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Open, Classified
LONNone listed
Aug 5, 2026Beckman Coulter Inc.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-2
Open, Classified
LONK201405
Aug 5, 2026Beckman Coulter Inc.
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instr
Open, Classified
LONK201405
Jul 9, 2026Biomerieux Inc
VITEK 2 AST-N447 TEST KIT Product reference 424620
Open, Classified
LONNone listed
Oct 23, 2025Becton Dickinson & Co.
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Open, Classified
LONK020321
K040099 +1
Sep 29, 2025bioMerieux, Inc.
VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification
Open, Classified
LONNone listed
Dec 3, 2024Becton Dickinson & Co.
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
Open, Classified
LONK020321
K040099 +1
Sep 24, 2024Becton Dickinson & Co.
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerob
Open, Classified
LONK020321
K040099 +1
Sep 24, 2024Becton Dickinson & Co.
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results fo
Open, Classified
LONK020321
K040099 +1
Apr 25, 2024Biomerieux Inc
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e)
Open, Classified
LONK161217
Mar 29, 2024Becton Dickinson & Co.
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical
Open, Classified
LONNone listed
Mar 29, 2024Becton Dickinson & Co.
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical
Open, Classified
LONK132674
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Open, Classified
LONK152075
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
Open, Classified
LONNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Open, Classified
LONNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Open, Classified
LONNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Open, Classified
LONK121100
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
Open, Classified
LONK032399
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Open, Classified
LONK041982
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Open, Classified
LONK040845
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
Open, Classified
LONNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
Open, Classified
LONK040485
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
Open, Classified
LONNone listed
Jan 4, 2023Biomerieux Inc
VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
Open, Classified
LONK040845
Jan 4, 2023Biomerieux Inc
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Open, Classified
LONNone listed
Nov 14, 2022Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selecte
Open, Classified
LONK070809
Mar 29, 2022bioMerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
Open, Classified
LONNone listed
Jan 28, 2021Biomerieux Inc
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). V
Terminated
LONK050002
Jan 28, 2021Biomerieux Inc
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 i
Terminated
LONK050002
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-posit
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos
Terminated
LONNone listed
Dec 8, 2020Becton Dickinson & Co.
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos
Terminated
LONNone listed
Mar 15, 2019bioMerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria
Terminated
LONNone listed
Jan 11, 2019Organon Teknika Inc
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222,
Terminated
LONNone listed
Jan 4, 2019Remel Inc.
SWIN 2017 database, Model YSW4000
Terminated
LONNone listed
Dec 20, 2018Becton Dickinson & Co.
Phoenix AP AST Indicator Bag, Catalog Number 246006
Terminated
LONK050745
Dec 20, 2018Becton Dickinson & Co.
Phoenix AST Indicator, Catalog Number 246004
Terminated
LONK050745
Dec 20, 2018Becton Dickinson & Co.
Phoenix AST-s Indicator, Catalog Number 246009
Terminated
LONK050745
Dec 13, 2018bioMerieux, Inc.
VITEK 2 AST-N351 Test Kit
Terminated
LONNone listed
Nov 13, 2018bioMerieux, Inc.
VITEK 2 Systems Software Version 9.01 Update Kit.
Terminated
LONK050002
Oct 22, 2018bioMerieux, Inc.
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 A
Terminated
LONNone listed
Aug 30, 2018bioMerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631
Terminated
LONK053097
Mar 23, 2018BioMerieux SA
The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobi
Terminated
LONNone listed

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