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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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Uric Acid is for the quantitative determination of uric acid in serum on Hitachi analyzers. For in vitro diagnostic use only. 9 x 65ml, 9 x 16ml.
POINTE SCIENTIFIC, INC.
HU982-729
In Commercial Distribution

  • 00811727013125 ()
HU982-729

  • Uric acid IVD, reagent
Uric Acid Reagent, for the quantitative determination of uric acid in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 100mL, 5 x 23mL
POINTE SCIENTIFIC, INC.
HU982-615
In Commercial Distribution

  • 00811727012791 ()
HU982-615

  • Uric acid IVD, reagent
Uric Acid Standard intended for use as an uric acid standard for standardization or calibration of uricase / trinder uric acid procedures. Packaged at 1 x 15ml
POINTE SCIENTIFIC, INC.
U7580-STD
In Commercial Distribution

  • 00811727012197 ()
U7580-STD

  • Uric acid IVD, reagent
Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 1L
POINTE SCIENTIFIC, INC.
U7581-1L
In Commercial Distribution

  • 00811727012180 ()
U7581-1L

  • Uric acid IVD, reagent
Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 500ml
POINTE SCIENTIFIC, INC.
U7581-500
In Commercial Distribution

  • 00811727012173 ()
U7581-500

  • Uric acid IVD, reagent
Uric Acid Liquid Reagent Set for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Packaged at 1 x 120ml
POINTE SCIENTIFIC, INC.
U7581-120
In Commercial Distribution

  • 00811727012166 ()
U7581-120

  • Uric acid IVD, reagent
No Description
VOLK OPTICAL INC.
VEAC
In Commercial Distribution

  • 00811608019246 ()


  • Laser lens, ophthalmic, surgical
ZOOM Coupler, F=16-34MM
SANTA BARBARA IMAGING SYSTEMS, INC.
84-10-2020
In Commercial Distribution

  • 00812231031957 ()
84-10-2020

  • Endoscope camera adaptor
ZEOS ZOOM COUPLER, F=16-34MM
SANTA BARBARA IMAGING SYSTEMS, INC.
84-10-2220
In Commercial Distribution

  • 00812231031858 ()
  • 00812231031605 ()
84-10-2220

  • Endoscope camera adaptor
No Description
AALTO SCIENTIFIC
K853M-20
In Commercial Distribution

  • B085K853M200 ()


  • Multiple traumatic brain injury marker IVD, control
No Description
AALTO SCIENTIFIC
K852M-20
In Commercial Distribution

  • B085K852M200 ()


  • Multiple traumatic brain injury marker IVD, control
No Description
AALTO SCIENTIFIC
K739M-10
In Commercial Distribution

  • B085K739M100 ()


  • Multiple traumatic brain injury marker IVD, control
No Description
AALTO SCIENTIFIC
K737M-5
In Commercial Distribution

  • B085K737M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
No Description
AALTO SCIENTIFIC
K713M-5
In Commercial Distribution

  • B085K713M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
No Description
AALTO SCIENTIFIC
K708M-5
In Commercial Distribution

  • B085K708M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Pointe Ecstasy (MDMA) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ecstasy (MDMA) Reagent Set is intended for the qualitative and semi-quantitative determination of MDMA and related compounds in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-EC0320-1L
In Commercial Distribution

  • 00811727018007 ()
60-EC0320-1L

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Pointe Ecstasy (MDMA) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ecstasy (MDMA) Reagent Set is intended for the qualitative and semi-quantitative determination of MDMA and related compounds in human urine at a cutoff value of 500 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-EC0320-100
In Commercial Distribution

  • 00811727017994 ()
60-EC0320-100

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
No Description
BIOGENEX LABORATORIES
AM338-5M
In Commercial Distribution

  • 00810119672049 ()

  • Total Volume: 6 Milliliter
AM338-5M

  • CD45 leukocyte common antigen cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM358-5M
In Commercial Distribution

  • 00810119671868 ()

  • Total Volume: 6 Milliliter
AM358-5M

  • Mucin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM241-5M
In Commercial Distribution

  • 00810119671455 ()

  • Total Volume: 6 Milliliter
AM241-5M

  • CD31 endothelial cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM134-5M
In Commercial Distribution

  • 00810119671363 ()

  • Total Volume: 6 Milliliter
AM134-5M

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
No Description
BIOGENEX LABORATORIES
AM997-5M
In Commercial Distribution

  • 00810119671141 ()

  • Total Volume: 6 Milliliter
AM997-5M

  • Cytomegalovirus (CMV) antigen IVD, antibody
No Description
BIOGENEX LABORATORIES
AM134-5M
In Commercial Distribution

  • 00810119670373 ()

  • Total Volume: 6 Milliliter
AM134-5M

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
No Description
BIOGENEX LABORATORIES
AN711-5M
In Commercial Distribution

  • 00810119670342 ()

  • Total Volume: 6 Milliliter
AN711-5M

  • Progesterone receptor IVD, antibody
No Description
BIOGENEX LABORATORIES
AM238-5M
In Commercial Distribution

  • 00810119670281 ()

  • Total Volume: 6 Milliliter
AM238-5M

  • CD20 cell marker IVD, antibody
Avalon Biomed by Zarc Z-Glider EVO File 31mm (015)
NUSMILE, LTD.
ZZGE00031
In Commercial Distribution

  • 00810118104558 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Avalon Biomed by Zarc Z-Glider EVO File 25mm (015)
NUSMILE, LTD.
ZZGE00025
In Commercial Distribution

  • 00810118104541 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Avalon Biomed by Zarc Z-Glider EVO File 21mm (015)
NUSMILE, LTD.
ZZGE00021
In Commercial Distribution

  • 00810118104534 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Avalon Biomed by Zarc BlueShaper PRO File 16mm (ZXS)
NUSMILE, LTD.
ZBS16PROZX
In Commercial Distribution

  • 00810118104527 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Avalon Biomed 38% Silver Diamine Fluoride (SDF) liquid – 4.0 ml bottle
NUSMILE, LTD.
ABSDF
In Commercial Distribution

  • 00810118104510 ()


  • Dental coating, tooth-desensitizing, professional
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