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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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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 Linezolid 0.016 – 256 μg/mL are specialized strips impregnated with a predefined concentration gradient of Linezolid for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecium (vancomycin resistant isolates only).
LIOFILCHEM SRL
Linezolid 0.016 – 256 μg/mL 10 strips
In Commercial Distribution

  • 18055182873323 ()
  • 08055182873326 ()
  • 08055182873302 ()
$92135-10

  • Linezolid minimum inhibitory concentration (MIC) IVD
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 Linezolid 0.016 – 256 μg/mL are specialized strips impregnated with a predefined concentration gradient of Linezolid for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecium (vancomycin resistant isolates only).
LIOFILCHEM SRL
Linezolid 0.016 – 256 μg/mL 1 strip
In Commercial Distribution

  • 28055182873313 ()
  • 08055182873319 ()
  • 18055182873316 ()
$92135-1

  • Linezolid minimum inhibitory concentration (MIC) IVD
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 Ceftazidime 0.016-256 are specialized strips impregnated with a predefined concentration gradient of Ceftazidime for susceptibility testing of Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgarism, Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftazidime 0.016-256 µg/mL 10 strips
In Commercial Distribution

  • 18055182870209 ()
  • 08055182870202 ()
  • 08055182870189 ()
$92138-10

  • Ceftazidime minimum inhibitory concentration (MIC) IVD
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 Ceftazidime 0.016-256 are specialized strips impregnated with a predefined concentration gradient of Ceftazidime for susceptibility testing of Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgarism, Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftazidime 0.016-256 µg/mL 1 strip
In Commercial Distribution

  • 28055182870190 ()
  • 08055182870196 ()
  • 18055182870193 ()
$92138-1

  • Ceftazidime minimum inhibitory concentration (MIC) IVD
The Chemcard™ Glucose Test is intended for use as a rapid, in vitro method for early identification of abnormal fasting plasma glucose concentration which can be a sign of diabetes or other medical problems. The Chemcard™ Glucose Test provides a preliminary, semi-quantitative result using fingerstick blood as the test specimen. 510K Cleared - CliaWaived
CHEMATICS, INC.
47000
In Commercial Distribution

  • 00737051736922 ()
  • 00737051736915 ()
  • 00737051736908 ()


  • Glucose IVD, kit, colorimetric dipstick, rapid
The SURGmatic S15 L Pro handpiece is intended for: • Oral, jaw and facial surgery • Tooth extraction procedures • Root resection • Osteotomy • Removal of carious material • Tooth, cavity and crown preparations • Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.
KaVo Dental GmbH
1.014.4000
In Commercial Distribution

  • EKAV101440000 ()
S15 L Pro

  • Dental power tool system handpiece, line-powered
No Description
Modern Dental Laboratory (DG) Co., Ltd.
314
In Commercial Distribution

  • 06972677873154 ()
  • 06972677873147 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic appliance system, bonded
  • Orthodontic retainer
The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101G
In Commercial Distribution

  • 00845533000031 ()
A92101G

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient’s blood glucose level in that target range. The system is programmed to provide dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-18) patients.
MEDICAL DECISION NETWORK, LLC
Insulin Dosing Calculator
In Commercial Distribution

  • 00861133000301 ()


  • Calculator, programmable
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 3 x 1g Sealant Syringe (Clear), 10 Dispensing Tips, 1 x 4g Alpha-Etch® 37 Syringe, 10 Dispensing Tips, 20 Disposable Brushes
DENTAL TECHNOLOGIES, INC.
401.0010.002
In Commercial Distribution

  • D73540100100020 ()
401.0010.002

  • Dental pit/fissure sealant
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