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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INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, COC, MET1000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3522
In Commercial Distribution

  • 10796918000931 ()
  • 00796918000934 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3520
In Commercial Distribution

  • 10796918000924 ()
  • 00796918000927 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/AMP/mAMP/THC/OPI)
ALERE SAN DIEGO, INC.
DOA-254
In Commercial Distribution

  • 10815845020642 ()
  • 00815845020645 ()
4012110099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007338 ()
  • 10850721007331 ()
  • 00850721007334 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007222 ()
  • 10850721007225 ()
  • 00850721007228 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007130 ()
  • 10850721007133 ()
  • 00850721007136 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
MEDICAL DISTRIBUTION GROUP INC
U-CUP-1254-RCN
In Commercial Distribution

  • 20850721007109 ()
  • 10850721007102 ()
  • 00850721007105 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007093 ()
  • 10850721007096 ()
  • 00850721007099 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Number One 5-Panel Drug Test Cup OPI/COC/MET/AMP/THC
UCP BIOSCIENCES, INC.
N1T-1105-P
In Commercial Distribution

  • 20817038022195 ()
  • 10817038022198 ()
  • 00817038022191 ()
N1T-1105-P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
UCP BIOSCIENCES, INC.
U-DOA-134
In Commercial Distribution

  • 20817038022126 ()
  • 10817038022129 ()
  • 00817038022122 ()
U-DOA-134

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6-Panel Drug Test Mini Cup BZO/COC/THC/OXY/OPI300/AMP
UCP BIOSCIENCES, INC.
U-MCUP-664-POC
In Commercial Distribution

  • 20817038020740 ()
  • 10817038020743 ()
  • 00817038020746 ()
U-MCUP-664-POC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/THC/OPI300/OXY/BUP
UCP BIOSCIENCES, INC.
U-CUP-1454-RCN
In Commercial Distribution

  • 20817038020610 ()
  • 10817038020613 ()
  • 00817038020616 ()
U-CUP-1454-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038020481 ()
  • 10817038020484 ()
  • 00817038020487 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002653 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AccuSign® DOA 2 THC/COC card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-221-10-02
In Commercial Distribution

  • 10743816000266 ()
DOA-221-10-02

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® DOA 2 THC/COC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-221-35-02
In Commercial Distribution

  • 10743816000259 ()
DOA-221-35-02

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 40810038636434 ()
  • 00810038636436 ()
  • 20810038636430 ()
EDOAP-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 30810038631685 ()
  • 00810038631684 ()
  • 10810038631681 ()
EDOAP-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10810038631384 ()
  • 00810038631387 ()
  • 30810038631388 ()
EDOAP-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 30810038630589 ()
  • 00810038630588 ()
  • 10810038630585 ()
EDOAP-754-5

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

  • 30810038630572 ()
  • 00810038630571 ()
  • 10810038630578 ()
EDOAP-254-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system
No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable
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
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable
Rapid Response Multi Drug Test Panels (COC/THC/AMP/OPI) - 25 tests/ kit are for the qualitative detection of Amphetamine, Opiates, THC and Cocaine metabolites in urine.
BTNX Inc
D4.1-1P29-25
In Commercial Distribution

  • 00722066000793 ()
  • 00722066003985 ()
D4.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel Drug Screen Dip Card Tests, COC/THC/MET/AMP, 25pcs/kit
CHEMTRON BIOTECH INC
711D02JAJ
In Commercial Distribution

  • 00850019007565 ()
711D02JAJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel DOA Dip Card, THC/COC/BAR/AMP/OPI2000/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711F03
In Commercial Distribution

  • 00850019007350 ()
711F03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET, 25pcs/kit
CHEMTRON BIOTECH INC
711D01
In Commercial Distribution

  • 00850019007299 ()
711D01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 2-Panel Drug Screen Dip Card Tests, COC/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711B01CT
In Commercial Distribution

  • 00850019007268 ()
711B01CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 7 BUP/BZO/COC/MTD/MOR300/OXY/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30723D
In Commercial Distribution

  • 00850019007107 ()
30723D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Dip Card, AMP/COC/MET/OPI2000/THC, 25 tests/kit
CHEMTRON BIOTECH INC
711E04
In Commercial Distribution

  • 00850019007824 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6, AMP/BZO/COC/MET/OPI2K/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60600D
In Commercial Distribution

  • 00850019007725 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Cup, AMP300/BZO200/COC150/MET300/OPI300/OXY/THC - 25tests/kit
CHEMTRON BIOTECH INC
712G01
In Commercial Distribution

  • 00850019007633 ()


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

  • 00850253007970 ()
  • 30850253007971 ()
  • 10850253007977 ()
EDOAP-264-15

  • 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

  • 10850253007960 ()
  • 00850253007963 ()
  • 30850253007964 ()
EDOAP-264-5

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

  • 10850253007403 ()
  • 00850253007406 ()
  • 30850253007407 ()


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

  • 10850253007397 ()
  • 00850253007390 ()
  • 30850253007391 ()


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