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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Amplichek - 03610520530054

Amplichek I Negative (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000527
In Commercial Distribution

  • 03610520530054 ()
12000527

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

Liquichek - 03610520530030

Liquichek Maternal Serum II Control Level 3 (A human serum assayed maternal control.)
BIO-RAD LABORATORIES, INC.
404
In Commercial Distribution

  • 03610520530030 ()
404

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520530023

Liquichek Maternal Serum II Control MiniPak (A human serum assayed maternal control.)
BIO-RAD LABORATORIES, INC.
403X
In Commercial Distribution

  • 03610520530023 ()
403X

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520530016

Liquichek Maternal Serum II Control Level 2 (A human serum assayed maternal control.)
BIO-RAD LABORATORIES, INC.
403
In Commercial Distribution

  • 03610520530016 ()
403

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520530009

Liquichek Maternal Serum II Control Level 1 (A human serum assayed maternal control.)
BIO-RAD LABORATORIES, INC.
402
In Commercial Distribution

  • 03610520530009 ()
402

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520267332

Liquichek Immunoassay Plus Control MiniPak (A human serum assayed immunoassay and TDM Control.)
BIO-RAD LABORATORIES, INC.
12004322
In Commercial Distribution

  • 03610520267332 ()
12004322

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520267325

Liquichek Immunoassay Plus Control Level 3 (A human serum assayed immunoassay and TDM Control.)
BIO-RAD LABORATORIES, INC.
12004321
In Commercial Distribution

  • 03610520267325 ()
12004321

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520267318

Liquichek Immunoassay Plus Control Level 2 (A human serum assayed immunoassay and TDM Control.)
BIO-RAD LABORATORIES, INC.
12004320
In Commercial Distribution

  • 03610520267318 ()
12004320

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610520267301

Liquichek Immunoassay Plus Control Level 1 (A human serum assayed immunoassay and TDM Control.)
BIO-RAD LABORATORIES, INC.
12004319
In Commercial Distribution

  • 03610520267301 ()
12004319

  • Multiple clinical chemistry protein IVD, control

InteliQ - 03610520267233

InteliQ Homocysteine Control MiniPak (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004312
In Commercial Distribution

  • 03610520267233 ()
12004312

  • Homocysteine IVD, control

InteliQ - 03610520267226

InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004311
In Commercial Distribution

  • 03610520267226 ()
12004311

  • Homocysteine IVD, control

InteliQ - 03610520267219

InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004310
In Commercial Distribution

  • 03610520267219 ()
12004310

  • Homocysteine IVD, control

InteliQ - 03610520242582

InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004309
In Commercial Distribution

  • 03610520242582 ()
12004309

  • Homocysteine IVD, control

Liquichek - 03610520174388

Liquichek Immunology Control Level 1 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003784
In Commercial Distribution

  • 03610520174388 ()
12003784

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 03610520174371

Liquichek Immunology Control Level 3 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003786
In Commercial Distribution

  • 03610520174371 ()
12003786

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 03610520174364

Liquichek Immunology Control Level 2 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003785
In Commercial Distribution

  • 03610520174364 ()
12003785

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 03610520174357

Liquichek Immunology Control MiniPak (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003787
In Commercial Distribution

  • 03610520174357 ()
12003787

  • Multiple-type clinical chemistry analyte profile IVD, control

Liofilchem Mic Test Strip (MTS) - 08055182872398

No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 10 Strip
In Commercial Distribution

  • 18055182872395 ()
  • 08055182872398 ()
  • 08055182872374 ()
$92071-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem Mic Test Strip (MTS) - 08055182872381

No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 1 Strip
In Commercial Distribution

  • 18055182872388 ()
  • 08055182872381 ()
  • 28055182872385 ()
$92071-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem Mic Test Strip (MTS) - 08055182872305

No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml 10 Strip
In Commercial Distribution

  • 18055182872302 ()
  • 08055182872305 ()
  • 08055182872282 ()
$92068-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182872299

No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml, 1 Strip
In Commercial Distribution

  • 28055182872293 ()
  • 08055182872299 ()
  • 18055182872296 ()
$92068-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870325

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 10 strips
In Commercial Distribution

  • 18055182870322 ()
  • 08055182870325 ()
  • 08055182870301 ()
$92074-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870318

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 1 strip
In Commercial Distribution

  • 28055182870312 ()
  • 08055182870318 ()
  • 18055182870315 ()
$92074-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870110

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 10 strip
In Commercial Distribution

  • 18055182870117 ()
  • 08055182870110 ()
  • 08055182870097 ()
$92084-10

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870103

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 1 strip
In Commercial Distribution

  • 28055182870107 ()
  • 08055182870103 ()
  • 18055182870100 ()
$92084-1

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870080

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 10 strips
In Commercial Distribution

  • 18055182870087 ()
  • 08055182870080 ()
  • 08055182870066 ()
$92146-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870073

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 1 strip
In Commercial Distribution

  • 28055182870077 ()
  • 08055182870073 ()
  • 18055182870070 ()
$92146-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

USA Elite System - 00821925002074

USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
Gyrus ACMI, LLC
EOS-CFR-25
In Commercial Distribution

  • 00821925002074 ()


  • General-purpose endoscopic needle, reusable

ETEST® Ceftaroline (CPT) - 03573026547509

Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
BIOMERIEUX SA
ETEST® Ceftaroline (CPT)
In Commercial Distribution

  • 03573026261658 ()
  • 03573026548568 ()
  • 03573026547509 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD

Etest® TIGECYCLINE - 03573026547295

Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
BIOMERIEUX SA
Etest® TIGECYCLINE
In Commercial Distribution

  • 03573026260866 ()
  • 03573026548186 ()
  • 03573026547295 ()


  • Antibacterial minimum inhibitory concentration (MIC) IVD
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