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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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CCDKM QC LEVEL 2
UTAK LABORATORIES, INC.
CCDKM QC 2 WB UK
In Commercial Distribution

  • B800CCDKMQC2WBUK5 ()
  • B800CCDKMQC2WBUK0 ()

  • Total Volume: 4 Milliliter
CCDKM QC 2 WB UK

  • Multiple-type clinical chemistry analyte profile IVD, control
CARISOPRODOL PLUS LEVEL 2
UTAK LABORATORIES, INC.
CARIS+ 2 S QD
In Commercial Distribution

  • B800CARIS2SQD5 ()
  • B800CARIS2SQD0 ()

  • Total Volume: 5 Milliliter
CARIS+ 2 S QD

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CONTROL LEVEL 2
UTAK LABORATORIES, INC.
BUS CONT 2 SJCRH
In Commercial Distribution

  • B800BUSCONT2SJCRH0 ()

  • Total Volume: 5 Milliliter
BUS CONT 2 SJCRH

  • Multiple drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
BENZU CP QC 2 V3
In Commercial Distribution

  • B800BENZUCPQC2V35 ()
  • B800BENZUCPQC2V30 ()

  • Total Volume: 1.2 Milliliter
BENZU CP QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2 V3
UTAK LABORATORIES, INC.
BENZO L2 V3 U F UW
In Commercial Distribution

  • B800BENZOL2V3UFUW5 ()
  • B800BENZOL2V3UFUW0 ()

  • Total Volume: 0.75 Milliliter
BENZO L2 V3 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-72691
Not in Commercial Distribution

  • 10856626006097 ()
  • 00856626006090 ()
993-72691

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3803-21
In Commercial Distribution

  • 00840487101186 ()
3803-21

  • Endogenous RNA internal control reagent IVD
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3803
In Commercial Distribution

  • 00840487101179 ()
3803

  • Endogenous RNA internal control reagent IVD
No Description
Dong Bang Medical co.,Ltd.
DB 310-2
In Commercial Distribution

  • 08800018914618 ()


  • Moxa
No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800068080010
In Commercial Distribution

  • 04034089054834 ()


  • Assistive pushchair
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