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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MassCheck® Steroid Panel 1&2, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0338
In Commercial Distribution

  • 04250317539809 ()
  • 04250317546685 ()

  • 5 x 3ml
0338

  • Multiple steroid hormone IVD, control
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2186G
In Commercial Distribution

  • D0692186G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2186C
In Commercial Distribution

  • D0692186C0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2184G
In Commercial Distribution

  • D0692184G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184C
In Commercial Distribution

  • D0692184C0 ()


  • Dental delivery system
4 Panel Home Drug Test Kit THC COC OPI MET
CONFIRM BIOSCIENCES, INC.
RO-DRC004
In Commercial Distribution

  • 00895330002370 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP
In Commercial Distribution

  • 20850721007376 ()
  • 10850721007379 ()
  • 00850721007372 ()
ID-CP5-DIP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 08 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY
REDWOOD TOXICOLOGY LABORATORY, INC.
011020179
In Commercial Distribution

  • 10858904006362 ()
  • 00858904006365 ()
DOA-184-521

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Panel 08 COC/ THC/AMP/MAMP/OPI2/MDMA/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020169
In Commercial Distribution

  • 10858904006300 ()
  • 00858904006303 ()
DOA-184-471

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000
Instant Technologies, Inc.
ABTDOAW14701A
In Commercial Distribution

  • 30817405023319 ()
  • 00817405023318 ()
  • 10817405023315 ()
ABTDOAW14701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)
JANT PHARMACAL CORPORATION
DS01AC425
In Commercial Distribution

  • 10763924001429 ()
  • 00763924001422 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80701
Not in Commercial Distribution

  • B313OT807011 ()
  • B313OT807010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET500-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60740-6
In Commercial Distribution

  • B29860740610 ()
60740-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI300-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
60613-6
In Commercial Distribution

  • B29860613610 ()
60613-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
31106-6
In Commercial Distribution

  • B2983110660 ()
31106-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET500-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI,GL
Express Diagnostic Int'l, Inc.
30908-6
In Commercial Distribution

  • B2983090860 ()
30908-6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 12 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC12P
In Commercial Distribution

  • 20612479255337 ()
  • 10612479255323 ()
  • 40612479255348 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
MCKESSON MEDICAL-SURGICAL INC.
16-DTDC10P
In Commercial Distribution

  • 20612479255306 ()
  • 10612479255293 ()
  • 40612479255317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1124A3
In Commercial Distribution

  • 20816490021098 ()
  • 10816490021091 ()
  • 00816490021094 ()
HDOA-1124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6124A3
In Commercial Distribution

  • 20816490020671 ()
  • 10816490020674 ()
  • 00816490020677 ()
HDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-254A3
In Commercial Distribution

  • 20816490020435 ()
  • 10816490020438 ()
  • 00816490020431 ()
HDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6125A3
In Commercial Distribution

  • 20816490022484 ()
  • 10816490022487 ()
  • 00816490022480 ()
HDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1104A3
In Commercial Distribution

  • 20816490021883 ()
  • 10816490021886 ()
  • 00816490021889 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-4104A3
In Commercial Distribution

  • 20816490021647 ()
  • 10816490021640 ()
  • 00816490021643 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-7104A3
In Commercial Distribution

  • 20816490021548 ()
  • 10816490021541 ()
  • 00816490021544 ()
HDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-654A3
In Commercial Distribution

  • 20816490020497 ()
  • 10816490020490 ()
  • 00816490020493 ()
HDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Control Panel
MICROBIOLOGICS INC.
8209
In Commercial Distribution

  • 70845357041325 ()
8209

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
MICROBIOLOGICS INC.
8208
In Commercial Distribution

  • 70845357041318 ()
8208

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
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