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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THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0502A-3A
Not in Commercial Distribution

  • 00816565020519 ()
C-C0502A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0501A-3A
Not in Commercial Distribution

  • 00816565020502 ()
C-C0501A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-9104
In Commercial Distribution

  • 10816862020769 ()
  • 00816862020762 ()
  • 00816862029765 ()
WDOA-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
WDOA-7104
In Commercial Distribution

  • 10816862020721 ()
  • 00816862020724 ()
  • 00816862029727 ()
WDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4105
In Commercial Distribution

  • 10816862020646 ()
  • 00816862020649 ()
  • 00816862029642 ()
WDOA-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4104
In Commercial Distribution

  • 10816862020639 ()
  • 00816862020632 ()
  • 00816862029635 ()
WDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-3104
In Commercial Distribution

  • 10816862020608 ()
  • 00816862020601 ()
  • 00816862029604 ()
WDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-1104
In Commercial Distribution

  • 10816862020493 ()
  • 00816862020496 ()
  • 00816862029499 ()
WDOA-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-8104
In Commercial Distribution

  • 10816862020332 ()
  • 00816862020335 ()
  • 00816862029338 ()
TDOA-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
TDOA-7104
In Commercial Distribution

  • 10816862020295 ()
  • 00816862020298 ()
  • 00816862029291 ()
TDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-4104
In Commercial Distribution

  • 10816862020202 ()
  • 00816862020205 ()
  • 00816862029208 ()
TDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-3104
In Commercial Distribution

  • 10816862020172 ()
  • 00816862020175 ()
  • 00816862029178 ()
TDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0501A-3A
Not in Commercial Distribution

  • 00816555020314 ()
C-C0501A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0502A-3A
Not in Commercial Distribution

  • 00816555020307 ()
C-C05020A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0503A-3A
Not in Commercial Distribution

  • 00816555020291 ()
C-C0503A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY
BRANAN MEDICAL CORPORATION
C-C1202A
Not in Commercial Distribution

  • 00816555020239 ()
C-C1202A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck SalivaScan Oral Fluid Drug Test, AMP COC MET OPI OXY THC
Express Diagnostic Int'l, Inc.
80617-EI
In Commercial Distribution

  • B29880617EI0 ()
80617-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4105
In Commercial Distribution

  • 00816862025644 ()
WDOA-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4104
In Commercial Distribution

  • 00816862025637 ()
WDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-3104
In Commercial Distribution

  • 00816862025606 ()
WDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-1104
In Commercial Distribution

  • 00816862025491 ()
WDOA-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-9104
In Commercial Distribution

  • 00816862025767 ()
WDOA-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
WDOA-7104
In Commercial Distribution

  • 00816862025729 ()
WDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-8104
In Commercial Distribution

  • 00816862025330 ()
TDOA-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
TDOA-7104
In Commercial Distribution

  • 00816862025293 ()
TDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-4104
In Commercial Distribution

  • 00816862025200 ()
TDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-3104
In Commercial Distribution

  • 00816862025170 ()
TDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-13104
In Commercial Distribution

  • 10816862024125 ()
  • 00816862024135 ()
  • 00816862024128 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square no THC with Indicator; AMP,COC,MET,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-366NTEUO-I
In Commercial Distribution

  • 10816862023432 ()
  • 00816862023435 ()
  • 00816862023442 ()
QODOA-366NTEUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cube; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
ODOA-10106EUO
In Commercial Distribution

  • 10816862022046 ()
  • 00816862022049 ()
  • 00816862022056 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 10810038630509 ()
  • 00810038630502 ()
  • 30810038630503 ()
EDOAP-264-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50
SYNTRON BIORESEARCH, INC.
60505
In Commercial Distribution

  • 20748349000056 ()
  • 10748349000059 ()
  • 00748349000052 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QSCREEN 4 Multi Test - COC 300, MET 1000, OPI 2000,THC 50
SYNTRON BIORESEARCH, INC.
60411
In Commercial Distribution

  • 20748349000339 ()
  • 10748349000332 ()
  • 00748349000335 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QuikScreen 4 Drug Cup - AMP 1000, COC 300, OPI 2000,THC 50
SYNTRON BIORESEARCH, INC.
60400
In Commercial Distribution

  • 20748349000209 ()
  • 00748349000205 ()
  • 10748349000202 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable
No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable
Pointe Cannabinoids (THC) Calibrator (200 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0158-5
In Commercial Distribution

  • 00811727017376 ()
60-TH0158-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Calibrator (150 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0156-5
In Commercial Distribution

  • 00811727017369 ()
60-TH0156-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
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