BEUDAMED
    Product Code: LON FDA class 2 21 CFR 866.1645

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    Microbiology

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation is an automated microbiology system that rapidly determines the susceptibility or resistance of bacterial isolates to a panel of antimicrobial agents using abbreviated incubation periods, providing clinically actionable results more quickly than conventional methods to guide antibiotic therapy selection. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LON, regulated under 21 CFR 866.1645, within the Microbiology medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    289
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    18
    Years Active
    40

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    Basic Information

    Product Code
    LON
    Device Class
    FDA class 2
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 289 510(k) clearances via K numbers.

    K Number Device Name
    K260282 VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
    K260281 VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
    K251579 VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
    K251713 BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
    K250447 BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
    K234012 VITEK COMPACT PRO
    K250344 BD Phoenix™ Automated Microbiology System
    K233986 BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
    K234000 VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
    K232756 Colibrí
    K232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
    K230864 VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
    K222378 VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
    K211748 Selux AST System; Model AST Gen 1.0
    K222430 VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
    K223478 VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
    K222073 VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
    K223481 VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
    K220803 VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
    K211759 Selux AST System; Model AST Gen 1.0
    K220805 VITEK 2 AST-Gram Positive Cefoxitin Screen
    K220546 Colibrí System
    K212243 VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
    K213899 VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
    K213931 VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
    K214023 VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
    K213241 VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
    K212849 VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
    K210287 VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
    K202396 VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
    K211630 VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
    K201675 VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
    K211136 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
    K193299 VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
    K201405 LabPro Data Management System
    K200590 VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
    K193572 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
    K193567 VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
    K192110 Vitek Densichek
    K191766 VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
    K190905 BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
    K190616 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
    K183524 VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
    K183551 VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
    K183360 VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
    K183415 VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
    K181766 VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
    K181665 BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
    K173523 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
    K173252 BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
    K172944 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
    K172731 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
    K162737 VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
    K163637 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
    K163563 VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
    K161437 VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
    K161510 VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
    K163083 VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)
    K163006 VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
    K161217 VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
    K161227 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
    K152075 VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
    K151320 BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
    K142170 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
    K141149 VITEK 2 AST GP CEFTAROLINE
    K140468 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
    K132909 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
    K132674 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
    K132507 VITEK 2 AST ST MEROPENEM
    K131779 VITEK 2 AST-ST TIGECYCLINE
    K132573 VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
    K131331 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
    K123404 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
    K123266 BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
    K121546 VITEK 2 GRAM NEGATIVE DOXYCYCLINE
    K121100 VITEK 2 AST STREPTOCOCUS VANCOMYCIN
    K122547 GRAM POSTITVE CLINDAMYCIN
    K122359 VITEK 2 STRPTOCOCCUS CEFTRIAXONE
    K121863 VITEK 2 AST-ST CEFOTAXIME
    K113783 VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
    K113200 VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
    K111893 VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
    K111976 VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
    K113305 VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
    K110106 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
    K112000 VITEK 2 STREPTOCOCCUS PENICILLIN
    K111909 VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
    K103752 VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
    K112228 VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
    K112129 VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
    K112075 VITEK 2 STRPTOCOCCUS AMPICILLIN
    K111599 VITEK 2 AST-ST LINEZOLID
    K093076 VITEK 2 GRAM POSITIVE DOXCYCLINE
    K093224 DENSICHECK PLUS
    K092919 MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
    K083536 DENSICHEK PLUS
    K091899 VITEK 2 GRAM NEGATIVE MEROPENEM
    K091126 VITEK 2 GRAM POSITIVE DAPTOMYCIN
    K082346 VITEK 2 GRAM NEGATIVE DORIPENEM
    K083383 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
    K082852 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
    K082913 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
    K082538 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
    K080201 VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
    K073589 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
    K080107 VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
    K073406 VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
    K073433 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
    K073083 VITEK 2 GRAM NEGATIVE PIPERACILLIN
    K072695 VITEK 2 GRAM POSITIVE TIGECYCLINE
    K072668 VITEK 2 GRAM POSITIVE VANCOMYCIN
    K070809 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
    K072038 VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
    K071623 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML
    K071317 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
    K070346 DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
    K071268 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
    K071076 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
    K070860 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
    K063486 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY
    K063824 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
    K063811 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML
    K063564 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML)
    K063300 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML
    K063597 VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
    K063623 VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE
    K063573 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML
    K063492 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
    K063366 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE
    K063365 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
    K063301 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML
    K062945 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
    K062938 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML
    K062944 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
    K062687 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML
    K062705 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID
    K062680 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML
    K062207 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML
    K062206 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
    K061869 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML
    K061867 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
    K061673 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML
    K061327 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.
    K061347 VITEK 2 GRAM POSITIVE VRSA SCREEN
    K061355 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML
    K060324 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE
    K060558 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
    K060447 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)
    K060257 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML
    K060444 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML
    K060217 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML
    K060493 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.
    K060312 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)
    K060218 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML
    K060214 BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML
    K053504 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)
    K060088 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
    K053241 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML
    K053097 VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
    K053186 VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
    K052656 VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
    K052346 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
    K052270 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
    K052269 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
    K052250 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
    K052311 VITEK 2 GRAM NEGATIVE TIGECYCLINE
    K051849 VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
    K051689 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML
    K051478 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
    K051350 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
    K051692 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML
    K051311 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN
    K051272 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
    K051266 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
    K051204 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
    K051183 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML
    K051109 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML
    K051138 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML
    K050946 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
    K050982 BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
    K050976 VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
    K050865 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML
    K050881 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML
    K050816 VITEK 2 GRAM POSITIVE MEROPENEM
    K050780 BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
    K050747 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
    K050745 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
    K050555 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
    K050400 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
    K043458 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
    K050089 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
    K050075 VITEK 2 GRAM POSITIVE DAPTOMYCIN
    K050076 VITEK 2 GRAM POSITIVE ERTAPENEM
    K050002 VITEK 2 COMPACT
    K043389 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML
    K043230 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
    K043237 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
    K042963 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
    K042946 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
    K042932 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML
    K041982 VITEK 2 GRAM NEGATIVE ERTAPENEM
    K041572 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
    K041384 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
    K040845 VITEK 2 ESBL TEST
    K033458 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
    K040716 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
    K033907 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML
    K033362 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
    K031601 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
    K040099 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K040106 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
    K032675 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
    K040006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
    K033889 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
    K033784 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
    K033560 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
    K033557 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
    K033558 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
    K033482 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
    K033064 MYCOPLASMA IGG
    K032861 VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
    K032788 VITEK 2 GRAM NEGATIVE GATIFLOXACIN
    K032766 VITEK 2 GRAM POSITIVE LINEZOLID
    K032738 VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
    K032711 VITEK GRAM NEGATIVE GATIFLOXACIN
    K032655 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
    K032275 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
    K032299 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
    K032567 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
    K032153 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
    K032399 VITEK 2 GRAM POSITIVE MOXIFLOXACIN
    K031984 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
    K032314 VITEK 2 GRAM POSITIVE GATIFLOXACIN
    K032131 BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS
    K031865 VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
    K031943 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML
    K031602 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)
    K031699 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML
    K031912 BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML
    K031679 BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
    K031589 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
    K031530 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
    K031410 VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
    K031429 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
    K031306 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE
    K030986 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
    K030677 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
    K030579 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
    K030091 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
    K024153 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
    K024152 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
    K023568 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K023895 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
    K023634 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
    K023527 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
    K023858 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K023361 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)
    K023541 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)
    K023444 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
    K023301 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K023273 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
    K022045 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
    K022172 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K021954 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
    K022129 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
    K020413 MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)
    K020410 MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)
    K020321 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K020398 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
    K020397 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)
    K020506 MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
    K020319 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
    K020323 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K020871 VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
    K020322 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
    K020870 VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
    K020248 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)
    K020142 MICROSCAN SYNERGIES PLUS
    K020511 MICROSCAN SYNERGIES PLUS
    K020328 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
    K020249 MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
    K020246 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
    K020209 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)
    K020185 MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)
    K020182 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)
    K020173 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
    K020168 MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
    K891577 SCEPTOR DATA MANAGEMENT CENTER SOFTWARE
    K861958 REPLIANALYZER

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.