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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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
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
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
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
5 panel RapidTox with THC/COC/OPI2000/AMP/BZO
AMERICAN BIO MEDICA CORPORATION
10-5ZT-200
In Commercial Distribution

  • 10694644150459 ()
  • 10694644100454 ()
10-5ZT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
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
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
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
Illumena Neo Contrast Delivery System, Rackmount Powerpack Panel (Accessory)
Liebel-Flarsheim Company LLC
900606
In Commercial Distribution

  • 10746190004912 ()


  • Angiography contrast medium injection system, line-powered, stationary
Multi Drug Test Panel (4.43) - BZO300 MET1000 BUP10 OPI2000
BTNX Inc
D4.43-1P29-25
In Commercial Distribution

  • 00722066005101 ()
  • 10722066005108 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80622
Not in Commercial Distribution

  • B313OT806221 ()
  • B313OT806220 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80605
Not in Commercial Distribution

  • B313OT806051 ()
  • B313OT806050 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80602
Not in Commercial Distribution

  • B313OT806021 ()
  • B313OT806020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox Device - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80509
Not in Commercial Distribution

  • B313OT805091 ()
  • B313OT805090 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-BZO-COC-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65520-5
Not in Commercial Distribution

  • B2986552050 ()
65520-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
65515-5
In Commercial Distribution

  • B29865515510 ()
65515-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65515-5
Not in Commercial Distribution

  • B2986551550 ()
65515-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65505-5
Not in Commercial Distribution

  • B2986550550 ()
65505-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
65500-5
In Commercial Distribution

  • B29865500510 ()
65500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65500-5
Not in Commercial Distribution

  • B2986550050 ()
65500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61307-5
In Commercial Distribution

  • B2986130750 ()
61307-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-TCA-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61243-5
Not in Commercial Distribution

  • B2986124350 ()
61243-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-TCA-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61211-5
Not in Commercial Distribution

  • B2986121150 ()
61211-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61208-5
Not in Commercial Distribution

  • B2986120850 ()
61208-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61207-5
Not in Commercial Distribution

  • B2986120750 ()
61207-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61202-5
Not in Commercial Distribution

  • B2986120250 ()
61202-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61129-5
In Commercial Distribution

  • B29861129510 ()
61129-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61129-5
Not in Commercial Distribution

  • B2986112950 ()
61129-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61121-5
In Commercial Distribution

  • B29861121510 ()
61121-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61121-5
Not in Commercial Distribution

  • B2986112150 ()
61121-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61103-5
Not in Commercial Distribution

  • B2986110350 ()
61103-5

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