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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AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07071 ()
  • B115ABCARD07070 ()
ABCard-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07061 ()
  • B115ABCARD07060 ()
ABCard-07-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP/BZO/COC/MDMA/MOR/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07041 ()
  • B115ABCARD07040 ()
ABCard-07-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/MET/MOR/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07031 ()
  • B115ABCARD07030 ()
ABCard-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AccuSign® THC card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-201-10-02
In Commercial Distribution

  • 10743816000044 ()
DOA-201-10-02

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® THC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-201-35-02
In Commercial Distribution

  • 10743816000037 ()
DOA-201-35-02

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460680 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460567 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Microgenics Corporation
10016433
In Commercial Distribution

  • 00884883012561 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
1557548
In Commercial Distribution

  • 00884883001947 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557530
In Commercial Distribution

  • 00884883001930 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557521
In Commercial Distribution

  • 00884883001923 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557513
In Commercial Distribution

  • 00884883001916 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
1557505
In Commercial Distribution

  • 00884883001909 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator
No Description
Microgenics Corporation
100100
In Commercial Distribution

  • 00884883001527 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
100091
In Commercial Distribution

  • 00884883001466 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system
Urine based drug of abuse test for THC
PHAMATECH, INCORPORATED
9078T
In Commercial Distribution

  • 00674033090781 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
(BZO/BAR)+(MET1000/OPI2000)+AMP+COC+THC DipCard
Twin Spirit Inc.
30730D
Not in Commercial Distribution

  • 00859144006269 ()
30730D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ALLDTHR
In Commercial Distribution

  • 30850054867620 ()
  • 00850054867629 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Chemtrue® THC Dip Card Test, 25pcs/kit
CHEMTRON BIOTECH INC
711A06CT
In Commercial Distribution

  • 00850019007206 ()
711A06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® Emit® II 5B3 THC Assay
Siemens Healthcare Diagnostics Inc.
10445468
Not in Commercial Distribution

  • 00842768023910 ()
9M979UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 5B3 THC Calibrator 50
Siemens Healthcare Diagnostics Inc.
10445466
Not in Commercial Distribution

  • 00842768002151 ()
9M839UL

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Incup with AMP/COC/OPI300/OXY/THC/SVT
AMERICAN BIO MEDICA CORPORATION
10-5SPCA-386
In Commercial Distribution

  • 10694644450740 ()
  • 10694644400745 ()
10-5SPCA-386

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Amp,OPI 300,THC +SVT
AMERICAN BIO MEDICA CORPORATION
10-3ACA-030
In Commercial Distribution

  • 10694644400660 ()
  • 10694644450665 ()
10-3ACA-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 InCup/Bzo,coc,op3, thc 25/cs
AMERICAN BIO MEDICA CORPORATION
10-4BC-030
In Commercial Distribution

  • 10694644400196 ()
  • 10694644450191 ()
10-4BC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 Pan InCup/Thc,coc,amp,opi 3
AMERICAN BIO MEDICA CORPORATION
10-4AC-030
In Commercial Distribution

  • 10694644400189 ()
  • 10694644450184 ()
10-4AC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Thc,coc,opi 300 ng
AMERICAN BIO MEDICA CORPORATION
10-3OC-030
In Commercial Distribution

  • 10694644400158 ()
  • 10694644450153 ()
10-3OC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6/coc,amp,meth,thc,bzo,opi3 BP
AMERICAN BIO MEDICA CORPORATION
10-6SPB-152
In Commercial Distribution

  • 10694644300489 ()
  • 10694644350484 ()
10-6SPB-152

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6/coc,amp,meth,thc,bzo,opi3 si
AMERICAN BIO MEDICA CORPORATION
10-6SP-152
In Commercial Distribution

  • 10694644300472 ()
  • 10694644350477 ()
10-6SP-152

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 RDS/COC,OXY,THC,Op3 CARD 50
AMERICAN BIO MEDICA CORPORATION
10-4OS-030
In Commercial Distribution

  • 10694644300243 ()
  • 10694644350248 ()
10-4OS-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 Pw/Thc,Coc,Meth,Opi 3 single
AMERICAN BIO MEDICA CORPORATION
10-4M1-030
In Commercial Distribution

  • 10694644300229 ()
  • 10694644350224 ()
10-4M1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 Pw/Thc,coc,Amp,Opi 3 sing
AMERICAN BIO MEDICA CORPORATION
10-4A1-030
In Commercial Distribution

  • 10694644300182 ()
  • 10694644350187 ()
10-4A1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan w/Thc, Coc, Opi 3, sing
AMERICAN BIO MEDICA CORPORATION
10-3O1-000
In Commercial Distribution

  • 10694644300137 ()
  • 10694644350132 ()
10-3O1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6RTC2/Bz/Coc/met/ox/thc/op3 SV
AMERICAN BIO MEDICA CORPORATION
10-6ZOX2A-030
In Commercial Distribution

  • 10694644200161 ()
  • 10694644250166 ()
10-6ZOX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6 RTC2/Bzo/Coc/met/oxy/thc/op3
AMERICAN BIO MEDICA CORPORATION
10-6ZOX2-030
In Commercial Distribution

  • 10694644200154 ()
  • 10694644250159 ()
10-6ZOX2-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTC II WITH THC/COC/OPI/AMP/PC
AMERICAN BIO MEDICA CORPORATION
10-5PX2B-200
In Commercial Distribution

  • 10694644200048 ()
  • 10694644250043 ()
10-5PX2B-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
PANEL 06 COC150/AMP1000/MAMP500/THC/MOP300/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020203
In Commercial Distribution

  • 10858904006638 ()
  • 00858904006631 ()
DOA-164-1551

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/MTD/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020017
In Commercial Distribution

  • 10858904006508 ()
  • 00858904006501 ()
DOA-864-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020024
In Commercial Distribution

  • 10858904006492 ()
  • 00858904006495 ()
DOA-964-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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