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Biomerieux Inc

146 FDA actions

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

bioMerieux, Inc.

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem

Biomerieux Inc

VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

bioMerieux, Inc.

VITEK COMPACT PRO

bioMerieux, Inc.

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

bioMerieux, Inc.

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

bioMerieux, Inc.

VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984;

Biomerieux Inc

VIDAS TBI (GFAP, UCH-L1)

bioMerieux, Inc.

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

bioMerieux, Inc.

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK

bioMerieux, Inc.

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-G

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

bioMerieux, Inc.

MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments

Biomerieux Inc

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

bioMerieux, Inc.

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

bioMerieux, Inc.

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-

bioMerieux, Inc.

PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

Biomerieux Inc

VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

Biomerieux Inc

VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

Biomerieux Inc

PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

Biomerieux Inc

VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437

Biomerieux Inc

ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218

Biomerieux Inc

ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449

Biomerieux Inc

VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416

Biomerieux Inc

BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

Biomerieux Inc

ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

Biomerieux Inc

ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

Biomerieux Inc

ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

Biomerieux Inc

ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560

Biomerieux Inc

VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

Biomerieux Inc

PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

Biomerieux Inc

API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

Biomerieux Inc

VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

Biomerieux Inc

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

Biomerieux Inc

VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893

Biomerieux Inc

VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

Biomerieux Inc

PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

Biomerieux Inc

ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

Biomerieux Inc

PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841

Biomerieux Inc

ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

Biomerieux Inc

VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

Biomerieux Inc

ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

Biomerieux Inc

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

Biomerieux Inc

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

Biomerieux Inc

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

Biomerieux Inc

API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

Biomerieux Inc

VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Biomerieux Inc

VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670

Biomerieux Inc

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

Biomerieux Inc

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

Biomerieux Inc

PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI

Biomerieux Inc

GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105

Biomerieux Inc

ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302

Biomerieux Inc

PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

Biomerieux Inc

VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706

Biomerieux Inc

PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

Biomerieux Inc

PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524

Biomerieux Inc

GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

Biomerieux Inc

ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

Biomerieux Inc

PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588

Biomerieux Inc

VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915

Biomerieux Inc

VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102

Biomerieux Inc

API NIT1 NIT2 REAGENTS, CATALOG 70442

Biomerieux Inc

BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

Biomerieux Inc

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

Biomerieux Inc

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

Biomerieux Inc

PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751

Biomerieux Inc

BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

Biomerieux Inc

VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401

Biomerieux Inc

ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

Biomerieux Inc

VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345

Biomerieux Inc

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Biomerieux Inc

PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871

Biomerieux Inc

ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

Biomerieux Inc

VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

Biomerieux Inc

ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

Biomerieux Inc

VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01

Biomerieux Inc

PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100

Biomerieux Inc

API VP1 VP2 REAGENTS, CATALOG 70422

Biomerieux Inc

PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035

Biomerieux Inc

API JAMES 2AMP, CATALOG 70542

Biomerieux Inc

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240

Biomerieux Inc

VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400

Biomerieux Inc

VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

Biomerieux Inc

ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262

Biomerieux Inc

VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341

Biomerieux Inc

ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

Biomerieux Inc

PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

Biomerieux Inc

PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR

Biomerieux Inc

ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331

Biomerieux Inc

BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017

Biomerieux Inc

ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

Biomerieux Inc

ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

Biomerieux Inc

ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392

Biomerieux Inc

VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072

Biomerieux Inc

PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586

Biomerieux Inc

VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

Biomerieux Inc

VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343

Biomerieux Inc

VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342

Biomerieux Inc

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252

Biomerieux Inc

VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219

Biomerieux Inc

VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

Biomerieux Inc

VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01

Biomerieux Inc

ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

Biomerieux Inc

ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445

Biomerieux Inc

VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404

Biomerieux Inc

DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

Biomerieux Inc

API 20 E 25 STRIPS, CATALOG 20100

Biomerieux Inc

VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

Biomerieux Inc

API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

Biomerieux Inc

VITEK 2 AST-Gram Positive Cefoxitin Screen

bioMerieux, Inc.

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

bioMerieux, Inc.

VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V

bioMerieux, Inc.

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

bioMerieux, Inc.

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

bioMerieux, Inc.

VITEK 2 Systems and VITEK 2 with MYLA.

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

bioMerieux, Inc.

VITEK MS PRIME

bioMerieux, Inc.

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconaz

bioMerieux, Inc.

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica

Biomerieux Inc

VIDAS RUB IgG (RBG), REF 30226

bioMerieux, Inc.

VIDAS FSH, REF 30407-01

bioMerieux, Inc.

VIDAS SARS-COV-2 IgM, Ref 423833-01

bioMerieux, Inc.

VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

bioMerieux, Inc.

VIDAS Estradiol II, REF 30431-01

bioMerieux, Inc.

VIDAS Lyme IgG II (LYM), REF 417401

bioMerieux, Inc.

VIDAS PRG Progesterone, REF 30409-01

bioMerieux, Inc.

VIDAS LH, REF 30406-01

bioMerieux, Inc.

VIDAS Measles IgG (MSG), REF 30219

bioMerieux, Inc.

VIDAS Clostridium Difficile GDH, REF 30125-01

bioMerieux, Inc.

VIDAS DEX@, Dimer Exclusion II, REF 30455-01

bioMerieux, Inc.

VIDAS Lyme IgM II (LYM), REF 416436

bioMerieux, Inc.

VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

bioMerieux, Inc.

VIDAS Mumps IgG (MPG), REF 30218

bioMerieux, Inc.

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Biomerieux Inc

VIDAS SARS-COV-2 IgG, Ref 423834-01

bioMerieux, Inc.

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

bioMerieux, Inc.

API 50 CH, Model 50300

bioMerieux, Inc.

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

bioMerieux, Inc.

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

bioMerieux, Inc.

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

bioMerieux, Inc.

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Biomerieux Inc

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

bioMerieux, Inc.