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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A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY S E
In Commercial Distribution

  • 04547410436983 ()


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1800 SE BATTERY E
In Commercial Distribution

  • 04547410426922 ()


  • Stationary basic diagnostic x-ray system, digital
A battery pack for the flat panel sensor.
FUJIFILM CORPORATION
DR1270 SE BATTERY E
In Commercial Distribution

  • 04547410355420 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1305SE incorporates a GOS indirect panel.
FUJIFILM CORPORATION
DR-ID 1305 SE E
In Commercial Distribution

  • 04547410322927 ()

  • 567.4x1339.8x50mm


  • Stationary basic diagnostic x-ray system, digital
Cepheid Xpert® C. difficile/Epi Control Panel
MICROBIOLOGICS INC.
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution

  • 70845357041370 ()
8200

  • Clostridium difficile nucleic acid IVD, control
BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX
CLINICAL REFERENCE LABORATORY, INC.
51013
Not in Commercial Distribution

  • 81781502510130 ()
51013

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC-pH,SG,OX
CLINICAL REFERENCE LABORATORY, INC.
51003
Not in Commercial Distribution

  • 81781502510031 ()
51003

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30903-3
Not in Commercial Distribution

  • B2983090330 ()
30903-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30802-3
Not in Commercial Distribution

  • B2983080230 ()
30802-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Dip Drug Test, AMP-COC-OPI300-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30401-3
Not in Commercial Distribution

  • B2983040130 ()
30401-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, AMP-COC-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30310-3
Not in Commercial Distribution

  • B2983031030 ()
30310-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, AMP-COC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30206-3
Not in Commercial Distribution

  • B2983020630 ()
30206-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Drug Test, AMP-COC-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30630-3
Not in Commercial Distribution

  • B2983063030 ()
30630-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Dip Drug Test, AMP-BZO-COC-MET-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30600-3
Not in Commercial Distribution

  • B2983060030 ()
30600-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, BZO-COC-MET-OPI300-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30573-3
Not in Commercial Distribution

  • B2983057330 ()
30573-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Dip Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
30572-3
Not in Commercial Distribution

  • B2983057230 ()
30572-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-OPI300-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60902-3
Not in Commercial Distribution

  • B2986090230 ()
60902-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI300-OXY-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60880-3
Not in Commercial Distribution

  • B2986088030 ()
60880-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Cup Drug Test, AMP-BAR-COC-MDMA-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60866-3
Not in Commercial Distribution

  • B2986086630 ()
60866-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60820-3
Not in Commercial Distribution

  • B2986082030 ()
60820-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60748-3
Not in Commercial Distribution

  • B2986074830 ()
60748-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BUP-BZO-MET-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60735-3
Not in Commercial Distribution

  • B2986073530 ()
60735-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BAR-BZO-COC-OPI-PPX-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60722-3
Not in Commercial Distribution

  • B2986072230 ()
60722-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BAR-BZO-COC-MTD-OPI-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60712-3
Not in Commercial Distribution

  • B2986071230 ()
60712-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-OPI300-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60705-3
Not in Commercial Distribution

  • B2986070530 ()
60705-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI300-OXY-THC-pH,SG,OX
Express Diagnostic Int'l, Inc.
60701-3
In Commercial Distribution

  • B29860701310 ()
60701-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60701-3
Not in Commercial Distribution

  • B2986070130 ()
60701-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET-OPI300-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60621-3
Not in Commercial Distribution

  • B2986062130 ()
60621-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-THC-pH,SG,OX
EXPRESS DIAGNOSTICS INT'L, INC.
60620-3
Not in Commercial Distribution

  • B2986062030 ()
60620-3

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