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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 MGB Alert Internal Control Set IC1-V consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-V can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800439
In Commercial Distribution

  • 03661540951633 ()
800439

  • Exogenous DNA/RNA internal control IVD, kit
Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
TELEFLEX INCORPORATED
IPN920672
In Commercial Distribution

  • 20801902196617 ()
  • 10801902196610 ()
PT-65709-WC

  • Thrombectomy rotational catheter
Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
TELEFLEX INCORPORATED
IPN920671
In Commercial Distribution

  • 20801902196600 ()
  • 10801902196603 ()
PT-12709-WC

  • Thrombectomy rotational catheter
Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-6010
In Commercial Distribution

  • D77819960101 ()

  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
199-6010

  • Dental composite resin
DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+ 3 WB IMMUN
In Commercial Distribution

  • B800DA3WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 3 WB IMMUN

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DA 3 WB F RIDH
In Commercial Distribution

  • B800DA3WBFRIDH5 ()
  • B800DA3WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 3 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 2
UTAK LABORATORIES, INC.
DA+2 WB V2 IMMUN
In Commercial Distribution

  • B800DA2WBV2IMMUN5 ()
  • B800DA2WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+2 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 1
UTAK LABORATORIES, INC.
DA+1 WB V2 IMMUN
In Commercial Distribution

  • B800DA1WBV2IMMUN5 ()
  • B800DA1WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+1 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA 1 S F LLS
In Commercial Distribution

  • B800DA1SFLLS5 ()
  • B800DA1SFLLS0 ()

  • Total Volume: 2 Milliliter
DA 1 S F LLS

  • Multiple drugs of abuse IVD, control
DA SET 1 POSITIVE
UTAK LABORATORIES, INC.
DA 1 POS WB NC
In Commercial Distribution

  • B800DA1POSWBNC5 ()
  • B800DA1POSWBNC0 ()

  • Total Volume: 2 Milliliter
DA 1 POS WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control
DA1FWBAHT
UTAK LABORATORIES, INC.
DA 1 F WB AHT
In Commercial Distribution

  • B800DA1FWBAHT5 ()
  • B800DA1FWBAHT0 ()

  • Total Volume: 5 Milliliter
DA 1 F WB AHT

  • Multiple-type clinical chemistry analyte profile IVD, control
DA SET 1 CUTOFF
UTAK LABORATORIES, INC.
DA 1 CUT S NC
In Commercial Distribution

  • B800DA1CUTSNC5 ()
  • B800DA1CUTSNC0 ()

  • Total Volume: 2 Milliliter
DA 1 CUT S NC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
CREATININE BASELINE
UTAK LABORATORIES, INC.
CREAT BL WB F LCG
In Commercial Distribution

  • B800CREATBLWBFLCG5 ()
  • B800CREATBLWBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT BL WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
CREATININE LEVEL 2
UTAK LABORATORIES, INC.
CREAT 2 WB F LCG
In Commercial Distribution

  • B800CREAT2WBFLCG5 ()
  • B800CREAT2WBFLCG0 ()

  • Total Volume: 50 Milliliter
CREAT 2 WB F LCG

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 2
UTAK LABORATORIES, INC.
COT+ 2 S LC
In Commercial Distribution

  • B800COT2SLC5 ()
  • B800COT2SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 2 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
COTININE PLUS LEVEL 1
UTAK LABORATORIES, INC.
COT+ 1 S LC
In Commercial Distribution

  • B800COT1SLC5 ()
  • B800COT1SLC0 ()

  • Total Volume: 5 Milliliter
COT+ 1 S LC

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL CAL
UTAK LABORATORIES, INC.
CORT SMX-OF F ARUP
In Commercial Distribution

  • B800CORTSMXOFFARUP5 ()
  • B800CORTSMXOFFARUP0 ()

  • Total Volume: 50 Milliliter
CORT SMX-OF F ARUP

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL LEVEL 2
UTAK LABORATORIES, INC.
CORT 2 SMX-OF F PP
In Commercial Distribution

  • B800CORT2SMXOFFPP5 ()
  • B800CORT2SMXOFFPP0 ()

  • Total Volume: 2 Milliliter
CORT 2 SMX-OF F PP

  • Multiple-type clinical chemistry analyte profile IVD, control
CORTISOL LEVEL 1
UTAK LABORATORIES, INC.
CORT 1 SMX-OF F PP
In Commercial Distribution

  • B800CORT1SMXOFFPP5 ()
  • B800CORT1SMXOFFPP0 ()

  • Total Volume: 1 Milliliter
CORT 1 SMX-OF F PP

  • Multiple-type clinical chemistry analyte profile IVD, control
COPPER PLUS LEVEL 2
UTAK LABORATORIES, INC.
COP+ 2 V2 S F UW
In Commercial Distribution

  • B800COP2V2SFUW5 ()
  • B800COP2V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 2 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
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