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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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CK-MB CAL - 05055273201451

The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.
RANDOX LABORATORIES LIMITED
CK2393
In Commercial Distribution

  • 05055273201451 ()
CK2393

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

C-QUR - 00650862313857

C-QUR FX, 5.7 in. x 4.1 in. (14.6 cm x 10.5 cm) 3D-LAPPATCH, W/HOLE,MED
Atrium Medical Corporation
31385
Not in Commercial Distribution

  • 00650862313857 ()


  • Extra-gynaecological surgical mesh, composite-polymer

C-QUR - 00650862313116

C-QUR FX, 2.5 in. x 5.5 in. (6.4 cm x 14 cm) W/O slit/hole
Atrium Medical Corporation
31311
Not in Commercial Distribution

  • 20650862313110 ()
  • 00650862313116 ()


  • Extra-gynaecological surgical mesh, composite-polymer

Calcitonin ELISA - B24221CALHUE010

The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
21-CALHU-E01
In Commercial Distribution

  • B24221CALHUE010 ()
21-CALHU-E01

  • Calcitonin IVD, kit, enzyme immunoassay (EIA)

ISE Serum Standard - 00811403019021

For use in the quantitative determination of Sodium, Potassium, and Chloride in Human Serum and Plasma.
Diamond Diagnostics Inc.
SM-B03417501D
In Commercial Distribution

  • 00811403019021 ()


  • Multiple electrolyte IVD, calibrator

POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010155

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
A7516-625
In Commercial Distribution

  • 00811727010155 ()
A7516-625

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010148

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
A7516-450
In Commercial Distribution

  • 00811727010148 ()
A7516-450

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

POINTE SCIENTIFIC Alkaline Phosphatase (Liquid) - 00811727010131

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
A7516-150
In Commercial Distribution

  • 00811727010131 ()
A7516-150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Alk Phos R2 (w/ssa#) - 00811727013736

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
13-A7516-R2-125
In Commercial Distribution

  • 00811727013736 ()
13-A7516-R2-125

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Alk Phos R1 (w/ssa#) - 00811727013729

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
13-A7516-R1-500
In Commercial Distribution

  • 00811727013729 ()
13-A7516-R1-500

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
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