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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AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP09031 ()
  • B115ABCUP09030 ()
ABCup-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BAR300/BZO300/COC300/MET1000/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06111 ()
  • B115ABCARDA06110 ()
ABCardA-06-11

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

  • B115ABCARDA06091 ()
  • B115ABCARDA06090 ()
ABCardA-06-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MDMA/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06081 ()
  • B115ABCARDA06080 ()
ABCardA-06-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET/MOR/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06041 ()
  • B115ABCARDA06040 ()
ABCardA-06-04

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

  • B115ABCARDA06011 ()
  • B115ABCARDA06010 ()
ABCardA-06-01

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

  • B115ABCARD09031 ()
  • B115ABCARD09030 ()
ABCard-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Co-Innovation Biotech Co., Ltd
THC Strip/3.0mm
In Commercial Distribution

  • 06970429840614 ()
  • 06970429840607 ()
  • 06970429840508 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use
THC/COC/AMP/MET/OPI drugs of abuse test cup
Twin Spirit Inc.
60500D
Not in Commercial Distribution

  • 00859144006207 ()
60500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/PCP/OPI drugs of abuse test cup
Twin Spirit Inc.
60505D
Not in Commercial Distribution

  • 00859144006191 ()
60505D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/BAR/OPI drugs of abuse test cup
Twin Spirit Inc.
60560D
Not in Commercial Distribution

  • 00859144006184 ()
60560D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
Instant Tech Subsidiary Acquisition
PSD-5N
Not in Commercial Distribution

  • 00858998006814 ()
PSD-5N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, COC/MET1000/OPI2000/PCP/THC
Instant Tech Subsidiary Acquisition
PSD-5MP
Not in Commercial Distribution

  • 00858998006807 ()
PSD-5MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, BZO/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5MB
Not in Commercial Distribution

  • 00858998006791 ()
PSD-5MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5M
Not in Commercial Distribution

  • 00858998006784 ()
PSD-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/BZO/COC/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSD-5AB
Not in Commercial Distribution

  • 00858998006777 ()
PSD-5AB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cassette, (COC/THC)+(MET1000/OPI2000)+AMP
Instant Tech Subsidiary Acquisition
PSP-5M
Not in Commercial Distribution

  • 00858998006722 ()
PSP-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSCup-5M-W
Not in Commercial Distribution

  • 00858998006500 ()
PSCup-5M-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, PCP, OPI drugs of abuse test cup
NEXSCREEN, LLC
60505N
In Commercial Distribution

  • 00858984006019 ()
60505N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, MET, OPI drugs of abuse test cup
NEXSCREEN, LLC
60500N
Not in Commercial Distribution

  • 00858984006002 ()
60500N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: THC
MERGERS MARKETING, INC.
PS-THC-114
In Commercial Distribution

  • 10850557007413 ()
  • 00850557007409 ()
  • 00850557007416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
100 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 00850253007994 ()
  • 30850253007995 ()
  • 10850253007991 ()
EDOAP-144-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
50 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 00850253007987 ()
  • 30850253007988 ()
  • 10850253007984 ()
EDOAP-144-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007892 ()
  • 00850253007895 ()
  • 30850253007896 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007885 ()
  • 00850253007888 ()
  • 30850253007889 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007878 ()
  • 00850253007871 ()
  • 30850253007872 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
ECDOA-254
In Commercial Distribution

  • 10850253007540 ()
  • 00850253007543 ()
  • 30850253007544 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
ECDOA-254
In Commercial Distribution

  • 10850253007533 ()
  • 00850253007536 ()
  • 30850253007537 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 10850253007304 ()
  • 00850253007307 ()
  • 30850253007308 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel DOA Cup, AMP/COC/MET/THC, 25 Tests/kit
CHEMTRON BIOTECH INC
712D01
In Commercial Distribution

  • 00850019007961 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, COC/MET/OPI2000/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712E06
In Commercial Distribution

  • 00850019007541 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, AMP/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712E01
In Commercial Distribution

  • 00850019007404 ()
712E01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 5, AMP/COC/MET/OPI/THC, 25pcs/kit
CHEMTRON BIOTECH INC
60500D
In Commercial Distribution

  • 00850019007114 ()
60500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 5, AMP/BAR/COC/OPI2000/THC ,25pcs/kit
CHEMTRON BIOTECH INC
30530D
In Commercial Distribution

  • 00850019007077 ()
30530D

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