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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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IDS SARS-COV-2 IgG Control Set - 05060169695979

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


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

IDS-iSYS Ostase® BAP Control Set - 05060169695818

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-2830US
In Commercial Distribution

  • 05060169695818 ()


  • Bone alkaline phosphatase (BALP) IVD, control

IDS SHBG Control Set - 05060169691339

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5630
In Commercial Distribution

  • 05060169691339 ()


  • Sex hormone binding globulin (SHBG) IVD, control

CK NAC - 05055273201505

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
RANDOX LABORATORIES LIMITED
CK3878
In Commercial Distribution

  • 05055273201505 ()
CK3878

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent

AMY - 05055273200577

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1582
Not in Commercial Distribution

  • 05055273200577 ()
AY1582

  • Amylase isoenzyme IVD, reagent

AMY - 05055273200560

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1580
In Commercial Distribution

  • 05055273200560 ()
AY1580

  • Amylase isoenzyme IVD, reagent

ALP - 05055273200362

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP3877
In Commercial Distribution

  • 05055273200362 ()
AP3877

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

INTEGRA - 00650551144113

INTEGRA CURVE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
PMT CORPORATION
3614-448
In Commercial Distribution

  • 00650551144113 ()

  • Total Volume: 2 Milliliter
  • Length: 1 Millimeter
  • Width: 2 Millimeter


  • Skin-port tissue expander

INTEGRA® - 00650551032564

TISSUE EXPANDER, ROUND, ENHANCED TEXTURED SURFACE
PMT CORPORATION
3611ES-310
In Commercial Distribution

  • 00650551032564 ()

  • Width: 2 Centimeter
  • Total Volume: 15 Centiliter
  • Length: 2 Centimeter
  • Projection 3 Centimeter
3611ES-310

  • Skin-port tissue expander

INTEGRA® - 00650551031512

TISSUE EXPANDER, ROUND, SMOOTH
PMT CORPORATION
3611-310
In Commercial Distribution

  • 00650551031512 ()

  • Width: 2 Centimeter
  • Total Volume: 15 Centiliter
  • Projection 3 Centimeter
  • Length: 2 Centimeter
3611-310

  • Skin-port tissue expander
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