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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1628
In Commercial Distribution

  • 09348215127596 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
IMMUNOSUPPRESSANTS QC 3
UTAK LABORATORIES, INC.
025090-0003
In Commercial Distribution

  • B80002509000033 ()
  • B80002509000030 ()

  • Total Volume: 10 Milliliter
IMMU 3 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 1
UTAK LABORATORIES, INC.
025090-0001
In Commercial Distribution

  • B80002509000013 ()
  • B80002509000010 ()

  • Total Volume: 10 Milliliter
IMMU 1 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 2
UTAK LABORATORIES, INC.
025090-0002
In Commercial Distribution

  • B80002509000020 ()
  • B80002509000023 ()

  • Total Volume: 10 Milliliter
IMMU 2 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030469 ()
MQP-51920

  • Nucleic acid library construction kit IVD
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030452 ()
MQP-50384

  • Nucleic acid library construction kit IVD
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030445 ()
MQP-50096

  • Nucleic acid library construction kit IVD
No Description
INTOUCH TECHNOLOGIES, INC.
Lite Remote Presence System V2
In Commercial Distribution

  • 00868772000150 ()


  • Diagnostic imaging telemedicine system
BENZODIAZEPINES LEVEL 2
UTAK LABORATORIES, INC.
BENZO 2 V2 U KP
In Commercial Distribution

  • B800BENZO2V2UKP5 ()
  • B800BENZO2V2UKP0 ()

  • Total Volume: 3 Milliliter
BENZO 2 V2 U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES 500 NG/ML
UTAK LABORATORIES, INC.
BARBS 500 U MAYO V2
In Commercial Distribution

  • B800BARBS500UMAYOV25 ()
  • B800BARBS500UMAYOV20 ()

  • Total Volume: 10 Milliliter
BARBS 500 U MAYO V2

  • Barbiturate IVD, control
BARBCALV2MLB
UTAK LABORATORIES, INC.
BARB+ CAL V2 M LB
In Commercial Distribution

  • B800BARBCALV2MLB0 ()

  • Total Volume: 0.5 Milliliter
BARB+ CAL V2 M LB

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCHOTICS URINE PLUS
UTAK LABORATORIES, INC.
ANTIPSYCH+ V2 U F OT
In Commercial Distribution

  • B800ANTIPSYCHV2UFOT5 ()
  • B800ANTIPSYCHV2UFOT0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V2 U F OT

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS
UTAK LABORATORIES, INC.
AMIT+ V2 U F BRL
In Commercial Distribution

  • B800AMITV2UFBRL5 ()
  • B800AMITV2UFBRL0 ()

  • Total Volume: 2 Milliliter
AMIT+ V2 U F BRL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
AED PLUS HIGH
UTAK LABORATORIES, INC.
AED+ H S V2 SCH
In Commercial Distribution

  • B800AEDHSV2SCH5 ()
  • B800AEDHSV2SCH0 ()

  • Total Volume: 5 Liter
AED+ H S V2 SCH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA M F PL V2
In Commercial Distribution

  • B800DAMFPLV25 ()
  • B800DAMFPLV20 ()

  • Total Volume: 5 Milliliter
DA M F PL V2

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE PLUS LEVEL 4
UTAK LABORATORIES, INC.
DA+4 WB V2 IMMUN
In Commercial Distribution

  • B800DA4WBV2IMMUN5 ()
  • B800DA4WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+4 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+3 WB V2 IMMUN
In Commercial Distribution

  • B800DA3WBV2IMMUN5 ()
  • B800DA3WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+3 WB V2 IMMUN

  • 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 LEVEL 2
UTAK LABORATORIES, INC.
DA 2 V2 WB NJSP
In Commercial Distribution

  • B800DA2V2WBNJSP5 ()
  • B800DA2V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
DA 2 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile 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 V2 WB NJSP
In Commercial Distribution

  • B800DA1V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
DA 1 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1
UTAK LABORATORIES, INC.
BENZO 1 V2 U KP
In Commercial Distribution

  • B800BENZO1V2UKP5 ()
  • B800BENZO1V2UKP0 ()

  • Total Volume: 3 Milliliter
BENZO 1 V2 U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZOYLECGONINE CONTROL 1
UTAK LABORATORIES, INC.
BE+ CONT 1 U V2
In Commercial Distribution

  • B800BECONT1UV25 ()
  • B800BECONT1UV20 ()

  • Total Volume: 5 Milliliter
BE+ CONT 1 U V2

  • Multiple therapeutic drugs/drugs of abuse IVD, control
ALPRAZOLAM PLUS 2
UTAK LABORATORIES, INC.
ALP+ 2 V2 S SH
In Commercial Distribution

  • B800ALP2V2SSH0 ()

  • Total Volume: 3 Milliliter
ALP+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
ALPRAZOLAM PLUS 1
UTAK LABORATORIES, INC.
ALP+ 1 V2 S SH
In Commercial Distribution

  • B800ALP1V2SSH5 ()
  • B800ALP1V2SSH0 ()

  • Total Volume: 3 Milliliter
ALP+ 1 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LOW
UTAK LABORATORIES, INC.
DAU V2 L QC SH
In Commercial Distribution

  • B800DAUV2LQCSH5 ()
  • B800DAUV2LQCSH0 ()

  • Total Volume: 3 Milliliter
DAU V2 L QC SH

  • Multiple drugs of abuse IVD, control
DAU HIGH
UTAK LABORATORIES, INC.
DAU V2 H QC SH
In Commercial Distribution

  • B800DAUV2HQCSH5 ()
  • B800DAUV2HQCSH0 ()

  • Total Volume: 3 Milliliter
DAU V2 H QC SH

  • Multiple drugs of abuse IVD, control
DAU QC KIT
UTAK LABORATORIES, INC.
DAU QC KIT V2 ABS
In Commercial Distribution

  • B800DAUQCKITV2ABS0 ()

  • Total Volume: 10 Milliliter
DAU QC KIT V2 ABS

  • Multiple drugs of abuse IVD, control
DAU POSITIVE
UTAK LABORATORIES, INC.
DAU POS V2 F CH
In Commercial Distribution

  • B800DAUPOSV2FCH5 ()
  • B800DAUPOSV2FCH0 ()

  • Total Volume: 10 Milliliter
DAU POS V2 F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU NEGATIVE
UTAK LABORATORIES, INC.
DAU NEG V2 F CH
In Commercial Distribution

  • B800DAUNEGV2FCH5 ()
  • B800DAUNEGV2FCH0 ()

  • Total Volume: 10 Milliliter
DAU NEG V2 F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
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