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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2 Panel Dip Drug Test, BUP-PPX
EXPRESS DIAGNOSTICS INT'L, INC.
30207
Not in Commercial Distribution

  • B298302070 ()
30207

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, OPI-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30206
Not in Commercial Distribution

  • B298302060 ()
30206

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, MDMA-PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30204
Not in Commercial Distribution

  • B298302040 ()
30204

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BUP-MET
EXPRESS DIAGNOSTICS INT'L, INC.
30203
Not in Commercial Distribution

  • B298302030 ()
30203

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30202
Not in Commercial Distribution

  • B298302020 ()
30202

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BZO-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30201
Not in Commercial Distribution

  • B298302010 ()
30201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-THC
Express Diagnostic Int'l, Inc.
30200
In Commercial Distribution

  • B2983020010 ()
30200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30200
Not in Commercial Distribution

  • B298302000 ()
30200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-MET500-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30301
Not in Commercial Distribution

  • B298303010 ()
30301

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-THC-MET
EXPRESS DIAGNOSTICS INT'L, INC.
30300
Not in Commercial Distribution

  • B298303000 ()
30300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BUP-MTD
EXPRESS DIAGNOSTICS INT'L, INC.
30224
Not in Commercial Distribution

  • B298302240 ()
30224

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, MTD-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30216
Not in Commercial Distribution

  • B298302160 ()
30216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC150-MET500
EXPRESS DIAGNOSTICS INT'L, INC.
30214
Not in Commercial Distribution

  • B298302140 ()
30214

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, MET500-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30213
Not in Commercial Distribution

  • B298302130 ()
30213

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BZO-OPI
EXPRESS DIAGNOSTICS INT'L, INC.
30210
Not in Commercial Distribution

  • B298302100 ()
30210

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC150-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30209
Not in Commercial Distribution

  • B298302090 ()
30209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC
Zerochaos
61020 ZC
Not in Commercial Distribution

  • B53961020ZC0 ()
61020 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC
Zerochaos
60505 ZC
Not in Commercial Distribution

  • B53960505ZC0 ()
60505 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA IA PANEL, cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008511
In Commercial Distribution

  • 00810042684188 ()
18008511

  • Multiple drugs of abuse IVD, control
DOA IA PANEL, cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008510
In Commercial Distribution

  • 00810042684171 ()
18008510

  • Multiple drugs of abuse IVD, control
OF 5 Panel, 3X Cutoff, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200005
In Commercial Distribution

  • 00810042683709 ()
18200005

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff +50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200177
In Commercial Distribution

  • 00810042683655 ()
18200177

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200176
In Commercial Distribution

  • 00810042683648 ()
18200176

  • Multiple drugs of abuse IVD, control
9 Panel Cutoff -/+ 25%, 5ML KITBOX
BIOCHEMICAL DIAGNOSTICS INC
18002907
In Commercial Distribution

  • 00810042680289 ()
18002907

  • Multiple drugs of abuse IVD, control
Top Sheet W/Clear Panel BNS
Cardinal Health 200, LLC
47187TNS
In Commercial Distribution

  • 50885380022874 ()
  • 10885380022876 ()
47187TNS

  • Patient surgical drape, single-use
For use the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5094
In Commercial Distribution

  • 07613336100592 ()
07862261001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
For use with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5092
In Commercial Distribution

  • 07613336100578 ()
07862245001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH6 antigen IVD, antibody
Operating panel for table top II
Baxter Medical Systems GmbH + Co. KG
1549939
Not in Commercial Distribution

  • 00887761974517 ()


  • Operating room equipment remote control
Rapid Multi-drug Test Cup, 10 Panel
Guangzhou Decheng Biotechnology Co., LTD
4851U2X001
Not in Commercial Distribution

  • 06974464590152 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Multi-drug Test Dipcard -6 Panel
Guangzhou Decheng Biotechnology Co., LTD
4821D2X005
Not in Commercial Distribution

  • 06974464590121 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TR2810 Shower panel with thermostatic mixer
Tr Equipment AB
0520070-02
In Commercial Distribution

  • 07350016060110 ()


  • Bathing/changing table, mobile
Triage TOX Drug Screen (7 Panel)
QUIDEL CARDIOVASCULAR INC.
94404
Not in Commercial Distribution

  • 30014613337898 ()
94404

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (9 Panel)
QUIDEL CARDIOVASCULAR INC.
94402
Not in Commercial Distribution

  • 30014613337881 ()
94402

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (10 Panel)
QUIDEL CARDIOVASCULAR INC.
94401
Not in Commercial Distribution

  • 30014613337874 ()
94401

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
25 tests kit; COC Single Panel
EASY HEALTHCARE CORPORATION
EDCO-114
In Commercial Distribution

  • 10810038631407 ()
  • 00810038631400 ()
  • 30810038631401 ()
EDCO-114-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Aptima® Mycoplasma genitalium Panel B.
HOLOGIC LTD.
KIT, M GEN PANEL B
In Commercial Distribution

  • 15420045509184 ()
PRD-03837

  • Mycoplasma genitalium nucleic acid IVD, reagent
ANTHEM FEMORAL TRIALS L PANEL SIZE1-6
Smith & Nephew, Inc.
71442135
In Commercial Distribution

  • 00885556613535 ()
71442135

  • Instrument tray, reusable
LEGION FEMORAL TRIALS L PANEL SIZE2-6
Smith & Nephew, Inc.
71442166
In Commercial Distribution

  • 00885556613528 ()
71442166

  • Instrument tray, reusable
ORTHOMATCH POSTERIOR STABILIZED PREPARATION PANEL SIZE1-8
Smith & Nephew, Inc.
71442168
In Commercial Distribution

  • 00885556613504 ()
71442168

  • Instrument tray, reusable
Detect Neg MIC Panel Type 1
Beckman Coulter, Inc.
B1020-100B
In Commercial Distribution

  • 15099590693404 ()
  • 05099590693407 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
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