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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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
5 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1354-RCN
In Commercial Distribution

  • 20817038020566 ()
  • 10817038020569 ()
  • 00817038020562 ()
U-CUP-1354-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup mAMP-COC-THC/MOP-MDMA/MTD/BAR-BZO/AMP/OXY
UCP BIOSCIENCES, INC.
U-CUP-3104
In Commercial Distribution

  • 20817038020559 ()
  • 10817038020552 ()
  • 00817038020555 ()
U-CUP-3104

  • 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
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
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX50YQS
In Commercial Distribution

  • 08809241513032 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX30TQS
In Commercial Distribution

  • 08809241513025 ()


  • Image display unit, colour
ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002
ACIST MEDICAL SYSTEMS, INC.
016227
In Commercial Distribution

  • 10841716101899 ()


  • Angiography contrast medium injection system, line-powered, mobile
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 2
Chromsystems Instruments + Chemicals GmbH
72039
In Commercial Distribution

  • 04250317533425 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72039

  • Multiple steroid hormone IVD, calibrator
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1
Chromsystems Instruments + Chemicals GmbH
72038
In Commercial Distribution

  • 04250317533340 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72038

  • Multiple steroid hormone IVD, calibrator
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY, FOREST GREY
Ls Enterprises, Inc.
3386WM-G
In Commercial Distribution

  • D0693386WMG0 ()


  • Dental delivery system
Knob with pointer, for control panel in the Xenon Administration System
Medi/Nuclear Corporation, Inc.
XE-102-23
In Commercial Distribution

  • 00850022357374 ()


  • Xenon administration system, diagnostic x-ray/CT
Flat Panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CW60
In Commercial Distribution

  • 08809241513063 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX20PUX
In Commercial Distribution

  • 08809241513056 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
CX30PQX
In Commercial Distribution

  • 08809241513049 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX50YQS
In Commercial Distribution

  • 08809241513018 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.
WIDE corporation
MX50TQS
In Commercial Distribution

  • 08809241513001 ()


  • Image display unit, colour
Healgen (DrugConfirm) - 5 Panel Dip Card - AMP1000/COC300/mAMP1000/MOP2000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-254
In Commercial Distribution

  • 00895330002707 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
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
Identify®Diagnostics Drug Test CardsTHC Single Panel Dip Test Card
MEDICAL DISTRIBUTION GROUP INC
ID-THC-DIP
In Commercial Distribution

  • 20850721007642 ()
  • 10850721007645 ()
  • 00850721007648 ()
ID-THC-DIP

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
PANEL 09 COC150/AMP300/BZO/MAMP500/MDMA/OPI300/OXY/PCP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020181
In Commercial Distribution

  • 10858904006386 ()
  • 00858904006389 ()
DOA-194-291

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020180
In Commercial Distribution

  • 10858904006379 ()
  • 00858904006372 ()
DOA-194-281

  • 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
VITEK REVEAL BC GN02-AST is an antibiotic panel (20 panels/box)
BIOMERIEUX , INC.
VITEK® REVEAL™ BC GN02-AST
In Commercial Distribution

  • 03573026638894 ()
  • 03573026638887 ()


  • Antibacterial susceptibility testing disc IVD
Beds LTC Accessories Product Description Staff Control Panel f/P703 ,1ea
Drive Devilbiss Healthcare
P703SC04
In Commercial Distribution

  • 00822383979564 ()


  • Electrical assistive bed
  • Basic electric home bed
CRL STAT 5 panel Dip - KCUR920106 AMP1000/COC300/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920106
In Commercial Distribution

  • 00817815021294 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Multi-Drug Screen Panel, OPI2000/MET1000/THC50/COC300/PCP25 Cassette Tests
CLINICAL REFERENCE LABORATORY, INC.
X04-PC12
In Commercial Distribution

  • 00817815021003 ()
X04-PC12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 5 panel Cup- KCUR920074 COC300/MET1000/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920074
In Commercial Distribution

  • 00817815020938 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel CLIA Waived Click Cup BUP10, BZO300, COC300, MOP300, MTD300
Instant Technologies, Inc.
ABTDOAW15702B
In Commercial Distribution

  • 30817405023869 ()
  • 00817405023868 ()
  • 10817405023865 ()
ABTDOAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel CLIA Waived Click Cup AMP1000/COC300/MET1000/MOP300/OXY100
Instant Technologies, Inc.
ABTDOAW15701A
In Commercial Distribution

  • 30817405023852 ()
  • 00817405023851 ()
  • 10817405023858 ()
ABTDOAW15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20
Instant Technologies, Inc.
ABTOFCUBE0502B
In Commercial Distribution

  • 30817405024057 ()
  • 00817405024056 ()
  • 10817405024053 ()
ABTOFCUBE0502B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel E&I Oral Click Cube AMP50, COC20, MET50, OPI40
Instant Technologies, Inc.
ABTOFCUBE0401A
In Commercial Distribution

  • 30817405023944 ()
  • 00817405023943 ()
  • 10817405023940 ()
ABTOFCUBE0401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10
Instant Technologies, Inc.
ABTOFCUBE0501A
In Commercial Distribution

  • 30817405023517 ()
  • 00817405023516 ()
  • 10817405023513 ()
ABTOFCUBE0501A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAK15701A
In Commercial Distribution

  • 30817405023494 ()
  • 00817405023493 ()
  • 10817405023490 ()
ABTDOAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel OralTox - AMP/COC/MET/MTD/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80807
Not in Commercial Distribution

  • B313OT808071 ()
  • B313OT808070 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC
AMEDITECH INC.
IMC-7P
Not in Commercial Distribution

  • 00816565020168 ()
IMC-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-264A3
In Commercial Distribution

  • 20816490023733 ()
  • 10816490023736 ()
  • 00816490023739 ()
HCDOAEW-264A3

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

  • 20816490022989 ()
  • 10816490022982 ()
  • 00816490022985 ()
DOAY-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-1144A3
In Commercial Distribution

  • 20816490022859 ()
  • 10816490022852 ()
  • 00816490022855 ()
DOAY-1144A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-2135A3
In Commercial Distribution

  • 20816490023351 ()
  • 10816490023354 ()
  • 00816490023357 ()
HCDOAEW-2135A3

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

  • 20816490023009 ()
  • 10816490023002 ()
  • 00816490023005 ()
DOAY-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-2135A3
In Commercial Distribution

  • 20816490022880 ()
  • 10816490022883 ()
  • 00816490022886 ()
DOAY-2135A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-1145A3
In Commercial Distribution

  • 20816490022866 ()
  • 10816490022869 ()
  • 00816490022862 ()
DOAY-1145A3

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

  • 20816490022637 ()
  • 10816490022630 ()
  • 00816490022633 ()
HCDOAEW-6125A3

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

  • 20816490022477 ()
  • 10816490022470 ()
  • 00816490022473 ()
HCDOAEC-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel
MICROBIOLOGICS INC.
8268
In Commercial Distribution

  • 70845357044364 ()
8268

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel
MICROBIOLOGICS INC.
8245
In Commercial Distribution

  • 70845357043695 ()
8245

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture)
MICROBIOLOGICS INC.
8243
In Commercial Distribution

  • 70845357043329 ()
8243

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel
MICROBIOLOGICS INC.
8211
In Commercial Distribution

  • 70845357041158 ()
8211

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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