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 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
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
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
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
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
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)
Inspiration Ventilator System, model 7i with 12" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000102US0 ()
F7300000-7i-S-US

  • General-purpose intensive-care ventilator
Inspiration Ventilator System, model 7i with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000101US0 ()
F7300000-7i-L-US

  • General-purpose intensive-care ventilator
BD MAX™ CT/GC/TV 20-Day QC Panel
MICROBIOLOGICS INC.
8193 BD MAX™ CT/GC/TV 20-Day QC Panel
Not in Commercial Distribution

  • 70845357041080 ()
8193

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Yeast Identification Panel
MICROBIOLOGICS INC.
5252P
In Commercial Distribution

  • 70845357040168 ()
5252P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Anaerobe Identification Panel
MICROBIOLOGICS INC.
5246P
In Commercial Distribution

  • 70845357039926 ()
5246P

  • Multiple bacteria species culture isolate identification control IVD, kit
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51215
Not in Commercial Distribution

  • 81781502512158 ()
51215

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51205
Not in Commercial Distribution

  • 81781502512059 ()
51205

  • 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
CLINICAL REFERENCE LABORATORY, INC.
51125
Not in Commercial Distribution

  • 81781502511250 ()
51125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51105
Not in Commercial Distribution

  • 81781502511052 ()
51105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51005
Not in Commercial Distribution

  • 81781502510055 ()
51005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50915
Not in Commercial Distribution

  • 81781502509158 ()
50915

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50905
Not in Commercial Distribution

  • 81781502509059 ()
50905

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50715
Not in Commercial Distribution

  • 81781502507154 ()
50715

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BAR-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50705
Not in Commercial Distribution

  • 81781502507055 ()
50705

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50505
Not in Commercial Distribution

  • 81781502505051 ()
50505

  • 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 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
8 Panel Cup Drug Test, AMP-BUP-BZO-COC-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60890-5
Not in Commercial Distribution

  • B2986089050 ()
60890-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-OPI300-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60856-5 BLK
Not in Commercial Distribution

  • B298608565BLK0 ()
60856-5 BLK

  • 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-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60820-5
Not in Commercial Distribution

  • B2986082050 ()
60820-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60746-5
In Commercial Distribution

  • B29860746510 ()
60746-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60746-5
Not in Commercial Distribution

  • B2986074650 ()
60746-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP500-COC150-MDMA-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60725-5
In Commercial Distribution

  • B29860725510 ()
60725-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MDMA-MET500-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60721-5
Not in Commercial Distribution

  • B2986072150 ()
60721-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BARB-BZO-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60708-5
In Commercial Distribution

  • B29860708510 ()
60708-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BAR-BZO-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60708-5
Not in Commercial Distribution

  • B2986070850 ()
60708-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, COC-MDMA-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60699-5
In Commercial Distribution

  • B29860699510 ()
60699-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, COC-MDMA-MET-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60699-5
Not in Commercial Distribution

  • B2986069950 ()
60699-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60689-5
In Commercial Distribution

  • B29860689510 ()
60689-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Cup Drug Test, AMP-COC-MET500-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60689-5
Not in Commercial Distribution

  • B2986068950 ()
60689-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
51105-DC
In Commercial Distribution

  • B29851105DC10 ()
51105-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
51005-DC
In Commercial Distribution

  • B29851005DC10 ()
51005-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
51005-DC
In Commercial Distribution

  • B29851005DC0 ()
51005-DC

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