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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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The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution

  • 00812117016818 ()
SECCDX-A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-500
In Commercial Distribution

  • 10629009145016 ()


  • Assay development analyte-specific reagent IVD
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.
Affinity Biologicals Inc
SAFXIII-IG-ASR-5
In Commercial Distribution

  • 10629009140516 ()


  • Assay development analyte-specific reagent IVD
Positive and Negative Oral Fluid Controls
BRANAN MEDICAL CORPORATION
OC001
Not in Commercial Distribution

  • 00816555020222 ()
OC001

  • Multiple drugs of abuse IVD, calibrator
SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S274
In Commercial Distribution

  • 00810000529551 ()
S274

  • Dental composite resin
SEcure® White Opaque Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S273
In Commercial Distribution

  • 00810000529544 ()
S273

  • Dental composite resin
SEcure® Translucent Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S272
In Commercial Distribution

  • 00810000529537 ()
S272

  • Dental composite resin
SEcure® Self-Etch Primer 3ml
PARKELL, INC.
S271
In Commercial Distribution

  • 00810000529520 ()
S271

  • Dental composite resin
SEcure® Resin Cement System Kit with Translucent Shade
PARKELL, INC.
S270
In Commercial Distribution

  • 00810000529513 ()
S270

  • Dental composite resin
CONTROL 550-13 CLOTTRAC HR 11L 30PK
MEDTRONIC, INC.
550-13
In Commercial Distribution

  • 20763000014876 ()
  • 00763000014872 ()


  • Multiple coagulation factor IVD, control
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