SEARCH RESULTS FOR: !ㅡ최신재테크디비구입금액%*텔레howDB(9274 results)

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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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Denture, restoration - 06972677874007

No Description
Modern Dental Laboratory (DG) Co., Ltd.
400
In Commercial Distribution

  • 06972677874014 ()
  • 06972677874007 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Partial denture
  • Complete upper denture
  • Complete lower denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Restoration - 06972677873604

No Description
Modern Dental Laboratory (DG) Co., Ltd.
360
In Commercial Distribution

  • 06972677873611 ()
  • 06972677873604 ()


  • Dental bridge, metal-polymer
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental casting non-noble alloy
  • Custom-made dental crown, metal

CARDINAL HEALTH - 10197106594889

D C PACK
Cardinal Health 200, LLC
SMA43DIEJC
In Commercial Distribution

  • 50197106594887 ()
  • 10197106594889 ()
SMA43DIEJC

  • Obstetrical/gynaecological surgical procedure kit, medicated

CARDINAL HEALTH - 10197106589601

SHY VP SHUNT PACK
Cardinal Health 200, LLC
SNEX4VSSSB
In Commercial Distribution

  • 50197106589609 ()
  • 10197106589601 ()
SNEX4VSSSB

  • Lumbar puncture kit

CARDINAL HEALTH - 10197106586150

MDSC D AND C PACK
Cardinal Health 200, LLC
SMA56DCMCA
In Commercial Distribution

  • 50197106586158 ()
  • 10197106586150 ()
SMA56DCMCA

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Access SARS-CoV-2 IgG II QC - 15099590742768

The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution

  • 15099590742768 ()
C69059

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Access SARS-CoV-2 IgG II Calibrator - 15099590742751

The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Access SARS-CoV-2 IgG II - 15099590742744

The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69057
In Commercial Distribution

  • 15099590742744 ()
C69057

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Access SARS-CoV-2 IgG QC - 15099590738662

The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution

  • 15099590738662 ()
C58964

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Access SARS-CoV-2 IgG Calibrator - 15099590738655

The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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