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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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
mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP
Mlife Diagnostics, LLC
M310501
In Commercial Distribution

  • G474M3105010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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
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
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
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
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
5 Panel Dip Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
30500-5
In Commercial Distribution

  • B29830500510 ()
30500

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30500-5
Not in Commercial Distribution

  • B2983050050 ()
30500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, COC-MDMA-MET-OPI300-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30581-5
Not in Commercial Distribution

  • B2983058150 ()
30581-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, AMP500-COC150-MET500-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
30501-5
In Commercial Distribution

  • B29830501510 ()
30501-5

  • 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
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