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 Clia Cup COC/THC/OPI/AMP/mAMP
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-254
In Commercial Distribution

  • 00895330002806 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
6 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-264
In Commercial Distribution

  • 00895330002721 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Alere Triage® Drugs of Abuse Panel Plus TCA
ALERE SAN DIEGO, INC.
92000
Not in Commercial Distribution

  • 00893038002104 ()
92000

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Alere Triage® 8 Panel for Drugs of Abuse
ALERE SAN DIEGO, INC.
90008
Not in Commercial Distribution

  • 00893038002098 ()
90008

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 4 Panel COC/OPI/mAMP/THC
RITE AID CORPORATION
8024510
In Commercial Distribution

  • 00011822001663 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
The T2Biothreat Panel component that contains the assay reagent
T2 BIOSYSTEMS, INC.
80-11394
In Commercial Distribution

  • M70880113930 ()
  • M70880113943 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
EMG USB Control Panel II Kit (With USB Cable)
NATUS NEUROLOGY INCORPORATED
045108
In Commercial Distribution

  • 00382830053082 ()


  • Electromyograph
MassCheck® Steroid Panel 2, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0346
In Commercial Distribution

  • 04250317533470 ()
  • 04250317545640 ()

  • 5 x 3ml
0346

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 2, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0345
In Commercial Distribution

  • 04250317533463 ()
  • 04250317545633 ()

  • 5 x 3ml
0345

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0343
In Commercial Distribution

  • 04250317533456 ()
  • 04250317545626 ()

  • 5 x 3ml
0343

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0342
In Commercial Distribution

  • 04250317533449 ()
  • 04250317545619 ()

  • 5 x 3ml
0342

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0341
In Commercial Distribution

  • 04250317533432 ()
  • 04250317545602 ()

  • 5 x 3ml
0341

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 2, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0347
In Commercial Distribution

  • 04250317533487 ()
  • 04250317545572 ()

  • 5 x 3ml
0347

  • Multiple steroid hormone IVD, control
ALPHA MULTISTORE PANEL PC 19" TOUCH SCREEN, MEDICAL GRADE
Gimmi GmbH
S.2046.50
In Commercial Distribution

  • 04049047653509 ()
S.2046.50

  • Endoscopic video imaging system
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY
Ls Enterprises, Inc.
3386WM
In Commercial Distribution

  • D0693386WM0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 2-HANDPIECE AUTOMATIC, FOREST GREY
Ls Enterprises, Inc.
2520G
In Commercial Distribution

  • D0692520G0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 2-HANDPIECE AUTOMATIC, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2520C
In Commercial Distribution

  • D0692520C0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC, FOREST GREY
Ls Enterprises, Inc.
2500G
In Commercial Distribution

  • D0692500G0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2500C
In Commercial Distribution

  • D0692500C0 ()


  • Dental delivery system
BD Respiratory Viral Panel for BD MAX™ System
BECTON, DICKINSON AND COMPANY
445373
In Commercial Distribution

  • 00382904453732 ()
445373

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
Medical Disposables Corp
M-DOA-824
In Commercial Distribution

  • 10851721007802 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel Test Card AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-254L
In Commercial Distribution

  • 20817038021143 ()
  • 10817038021146 ()
  • 00817038021149 ()
U-DOA-254L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/AMP/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020177
In Commercial Distribution

  • 10858904006355 ()
  • 00858904006358 ()
DOA-174-721

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/BZO/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020176
In Commercial Distribution

  • 10858904006348 ()
  • 00858904006341 ()
DOA-174-711

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,XXL
MEDLINE INDUSTRIES, INC.
SYN7805XXL
In Commercial Distribution

  • 40884389172293 ()
  • 10884389172292 ()
SYN7805XXL

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,L
MEDLINE INDUSTRIES, INC.
SYN7803L
In Commercial Distribution

  • 40884389172286 ()
  • 10884389172285 ()
SYN7803L

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,S
MEDLINE INDUSTRIES, INC.
SYN7801S
In Commercial Distribution

  • 40884389172279 ()
  • 10884389172278 ()
SYN7801S

  • Surgical gown, reusable
BINDER, ABDOMINAL, 12" 2XL (62"-75"), 4 PANEL, WHITE
Asp Global, LLC
10582XL-ASP
In Commercial Distribution

  • 00840216117587 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" 2XL (62"-75"), 3 PANEL, WHITE
Asp Global, LLC
10572XL-ASP
In Commercial Distribution

  • 00840216117570 ()


  • Abdominal binder, reusable
I5 Printer soiled side, includes mounting panel and cables
SKYTRON LLC
I5-PRSS
In Commercial Distribution

  • 10841736100537 ()
I5-PRSS

  • Surgical instrument washer/disinfector (chemical/thermal)
I5 Printer clean side, includes mounting panel and cables
SKYTRON LLC
I5-PRCS
In Commercial Distribution

  • 10841736100513 ()
I5-PRCS

  • Surgical instrument washer/disinfector (chemical/thermal)
CVi Angiographic Injection System Control Panel, p/n 701557-001
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 10841716101196 ()


  • Angiography contrast medium injection system, line-powered, mobile
CVi Angiographic Injection System Control Panel, p/n 700771-005
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 30841716100629 ()
  • 10841716100625 ()


  • Angiography contrast medium injection system, line-powered, mobile
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-THC-FEN-MDMA-OXY-PCP
Mlife Diagnostics, LLC
MV002.09.0001EI
In Commercial Distribution

  • G474MV002090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MV002.06.0001EI
In Commercial Distribution

  • G474MV002060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MV001.10.0003EI
In Commercial Distribution

  • G474MV001100003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-6MAM-MDMA-OXY
Mlife Diagnostics, LLC
MV001.09.0003EI
In Commercial Distribution

  • G474MV001090003EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-THC
Mlife Diagnostics, LLC
MV001.09.0002-EI
In Commercial Distribution

  • G474MV001090002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 9 panel oral fluid drug test AMP-COC-MDMA-THC-MET-OPI-OXY-PCP-FEN
Mlife Diagnostics, LLC
MV001.09.0001-EI
In Commercial Distribution

  • G474MV001090001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 8 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC-MDMA-OXY
Mlife Diagnostics, LLC
MV001.08.0001EI
In Commercial Distribution

  • G474MV001080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MV001.06.0001-EI
In Commercial Distribution

  • G474MV001060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Verify 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
MV001.05.0001-EI
In Commercial Distribution

  • G474MV001050001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 11 panel oral fluid drug test AMP-BAR-BZO-COC-FYL-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC002.11.0001EI
In Commercial Distribution

  • G474MC002110001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC002.10.0001EI
In Commercial Distribution

  • G474MC002100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 8 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-OXY-BAR-BZO-MDMA
Mlife Diagnostics, LLC
MC002.08.0001EI
In Commercial Distribution

  • G474MC002080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC001.10.0001-EI
In Commercial Distribution

  • G474MC001100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MC001.06.0001-EI
In Commercial Distribution

  • G474MC001060001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-THC
Mlife Diagnostics, LLC
MC001.05.0002EI
In Commercial Distribution

  • G474MC001050002EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
MC001.05.0001-EI
In Commercial Distribution

  • G474MC001050001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
M310601
In Commercial Distribution

  • G474M3106010 ()


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