bioMerieux, Inc.

VITEK 2 AST- Gram Positive Telavancin VITEK 2 AST - Gram Negative Imipenem VITEK 2 AST Streptococcus Ceftriaxone VITEK 2 AST-Yeast Caspofungin VITEK 2 GP Telithromycin for S. pneumo AST Streptococcus Vancomycin VITEK 2 Streptococcus Tetracycline VITEK 2 Gram Positive Erythromycin VITEK 2 Gram Positive Ertapenem VITEK 2 GRAM POSITIVE DOXCYCLINE VITEK 2 Gram Positive Tigecycline VITEK 2 AST-Gram Positive Moxifloxacin VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE VITEK 2 AST-Yeast Voriconazole VITEK 2 Gram Positive Daptomycin VITEK 2 Gram Positive Gatifloxacin BACT/ALERT PF PLUS CULTURE BOTTLE VITEK 2 AST-GN Levofloxacin VITEK 2 AST-GP Penicillin G VITEK 2 AST-GP Streptomycin, HL VITEK 2 AST-GP Clindamycin VITEK 2 AST-GN Imipenem VITEK 2 AST-GN Tobramycin VITEK 2 AST-GP Ciprofloxacin VITEK 2 AST-GN Cefazolin VITEK 2 AST-GP Erythromycin VITEK 2 AST-GP Gentamicin, HL VITEK 2 AST-GN Cefpodoxime VITEK 2 AST-GP for S.pn Penicillin G VITEK 2 AST-GN Tetracycline VITEK 2 AST-GP for S.pn Ofloxacin VITEK 2 AST-GN Cefalotin VITEK 2 AST-GP Levofloxacin VITEK 2 AST-GN Cefuroxime VITEK 2 AST-GP Rifampin VITEK 2 AST-GN Meropenem VITEK 2 AST-GN Ceftriaxone VITEK 2 AST-GP Sparfloxacin VITEK 2 AST-GN Gentamicin VITEK 2 AST-GN Ampicillin VITEK 2 AST-GP Gentamicin VITEK 2 AST-GP for S.pn Tetracycline VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn) VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid VITEK 2 AST-GP for S.pn Chloramphenicol VITEK 2 AST-GP Amp/Sulbactam VITEK 2 AST-GN Nitrofurantoin VITEK 2 AST-GN Amox/Clav VITEK 2 AST-GN Nalidixic Acid VITEK 2 AST-GN Ciprofloxacin VITEK 2 AST-GP for S.pn Cefotaxime VITEK 2 AST-GN Amp/Sulbactam VITEK 2 AST-GN Piperacillin VITEK 2 AST-GP Cefazolin VITEK 2 AST-GN Ticarcillin VITEK 2 AST-GN Cefoxitin VITEK 2 AST-GP for S.pn Trimeth./sulfa VITEK 2 AST-GN Pip/Tazob. VITEK 2 AST-GP Chloramphenicol VITEK 2 AST-GN Amikacin VITEK 2 AST-GN Norfloxacin VITEK 2 AST-GP Norfloxacin VITEK 2 AST-GN Cefepime VITEK 2 AST-GN Trimeth./sulfa VITEK 2 AST-GP Nitrofurantoin VITEK 2 AST-GP Ofloxacin VITEK 2 AST-GN Ceftazidime VITEK 2 AST-GP for S.pn Vancomycin VITEK 2 AST-GP Minocycline VITEK 2 AST-GN Cefotaxime VITEK 2 AST-GN Aztreonam VITEK 2 AST-GN Cefotetan VITEK 2 AST-GP for S.pn Ceftriaxone VITEK 2 AST-GN Ceftizoxime VITEK 2 AST-GP Vancomycin VITEK 2 AST-GP Tetracycline VITEK 2 AST-GP Ampicillin VITEK 2 AST-GP Oxacillin VITEK 2 Gram Positive Linezolid AST-GN Imipenem BacT/ALERT 3D with Mycobacterium Indication VITEK 2 AST-Gram Positive Cefoxitin Screen VITEK 2 GP Amoxicillin for S pneumo VITEK 2 AST-Gram Negative Omadacycline DensiCHEK Plus VITEK 2 Compact VITEK 2 Gram Negative Tigecycline VITEK 2 AST-Gram Positive Fosfomycin BACT/ALERT FN PLUS VITEK 2 GN Doxycycline VITEK 2 AST-GN Piperacillin/tazobactam VITEK 2 AST-Streptococcus Penicillin VITEK 2 AST- Gram Negative Polymyxin B VITEK 2 AST-ST Erythromycin VITEK 2 Gram Negative Ceftriaxone VITEK 2 GP Sparfloxacin for S.pn VITEK DENSICHEK VITEK 2 ESBL Test VITEK 2 AST-ST Ampicillin VITEK 2 AST-GP Ceftaroline VITEK 2 Gram Positive Vancomycin VITEK 2 AST-Gram Negative Tobramycin BacT/ALERT FA (Plastic Bottle) AST Clindamycin VITEK 2 AST-Gram Negative Levofloxacin and BacT/ALERT 3D60 Instrument 3D Combination BacT/ALERT Blood Culturing System (240), VITEK 2 GP Levofloxacin for VITEK 2 AST-Gram Negative Piperacillin / Tazobactam VITEK 2 Gram Negative Levofloxacin VITEK 2 AST-GN Tigecycline VITEK 2 AST-ST Levofloxacin VITEK 2 AST-Gram Negative Plazomicin VITEK 2 Streptococcus Penicillin VITEK 2 Gram Negative Piperacillin Trimethoprim / Sulfamethoxazole VITEK 2 Gram Positive VITEK 2 AST-Gram Negative Meropenem/Vaborbactam VITEK® 2 AST-GN Gentamicin VITEK 2 Streptococcus Trimethoprim/Sulfamethoxazole VITEK 2 GP Erythromycin for BacT/ALERT SN (Plastic Bottles) VITEK 2 AST-ST Inducible Clindamycin Resistance VITEK 2 Gram Positive VRSA Screen VITEK 2 AST - Gram Negative Ertapenem VITEK 2 Gram Negative Doripenem VITEK 2 AST-ST Clindamycin VITEK 2 Gram Negative Gatifloxacin VITEK 2 Gram Positive Meropenem VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) VITEK 2 AST-ST Tigecycline VITEK 2 AST-Gram Positive Lefamulin VITEK 2 AST-Gram Negative Minocycline AST Penicillin VITEK 2 AST-Gram Positive Linezolid VITEK 2 AST-Gram Positive Daptomycin Vitek 2 AST Gram Negative Cefazolin VITEK 2 AST-Gram Positive Dalbavancin VITEK 2 AST-ST Meropenem VITEK 2 AST-Gram Negative Ciprofloxacin VITEK 2 Gram Positive Inducible Clindamycin Resistance VITEK2 AST-Gram Negative Delafloxacin VITEK 2 AST Gram Negative Cefotaxime VITEK 2 AST-Gram Negative Ceftazidime BACT/ALERT MP Reagent System BacT/ALERT FN (Plastic Bottles) AST Cefotaxime BacT/ALERT VIRTUO Microbial Detection System VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance VITEK 2 AST-Gram Negative Imipenem/Relebactam VITEK 2 AST-Gram Negative Fosfomycin VITEK 2 GP Moxifloxacin for VITEK 2 AST-Gram Negative Eravacycline VITEK 2 Gram Negative Trimethoprim/Sulfamethoxazole BACT/ALERT FA PLUS CULTURE BOTTLE VITEK 2 AST-Gram Negative Meropenem VITEK 2 AST-Gram Positive Delafloxacin VITEK 2 GP Meropenem for VITEK 2 Gram Positive Moxifloxacin VITEK 2 Gram Negative Ertapenem VITEK 2 AST-ST Moxifloxacin VITEK 2 AST-GN Ceftolozane/Tazobactam VITEK 2 GP for Quinupristin / Dalfopristin VITEK 2 GP Ertapenem for S. pneumo BacT/ALERT FA Plus BacT/ALERT PF Plus VITEK 2 GP Linezolid for S. pneumo VITEK 2 AST-Yeast Anidulafungin VITEK 2 Gram Negative Moxifloxacin (<= 0.12 - >= 8 mcg/ml) BacT/ALERT SA (Plastic Bottles) BacT/ALERT PF (Plastic Bottles) VITEK 2 Gram Negative Meropenem VITEK 2 AST- Streptococcus Cefotaxime VITEK 2 AST-Yeast Fluconazole VITEK 2 GP Cefoxitin Screen VITEK 2 AST-ST Linezolid for Pipercillin/Tazobactam VITEK 2 AST-GN Ceftazidime/Avibactam

Complaint File Establishment per 21 CFR 820.198