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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4 Panel Dip Drug Test, BZO-MTD-OPI300-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30404
Not in Commercial Distribution

  • B298304040 ()
30404

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Dip Drug Test, BZO-COC-MTD-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30403
Not in Commercial Distribution

  • B298304030 ()
30403

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Dip Drug Test, BZO-COC-MTD-OPI
EXPRESS DIAGNOSTICS INT'L, INC.
30402
Not in Commercial Distribution

  • B298304020 ()
30402

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

  • B298304010 ()
30401

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Dip Drug Test AMP-COC-OPI-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30400
Not in Commercial Distribution

  • B298304000 ()
30400

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, AMP-COC-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30341
Not in Commercial Distribution

  • B298303410 ()
30341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BZO-MTD-OPI
EXPRESS DIAGNOSTICS INT'L, INC.
30325
Not in Commercial Distribution

  • B298303250 ()
30325

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BUP-OPI300-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30324
Not in Commercial Distribution

  • B298303240 ()
30324

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, MTD-OPI300-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30323
Not in Commercial Distribution

  • B298303230 ()
30323

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, AMP-MDMA-MET
EXPRESS DIAGNOSTICS INT'L, INC.
30321
Not in Commercial Distribution

  • B298303210 ()
30321

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, MDMA-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30320
Not in Commercial Distribution

  • B298303200 ()
30320

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BZO-COC-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30319
Not in Commercial Distribution

  • B298303190 ()
30319

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, AMP-COC-MDMA
EXPRESS DIAGNOSTICS INT'L, INC.
30318
Not in Commercial Distribution

  • B298303180 ()
30318

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-OPI-THC
Express Diagnostic Int'l, Inc.
30315
In Commercial Distribution

  • B2983031510 ()
30315

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-OPI-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30315
Not in Commercial Distribution

  • B298303150 ()
30315

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BUP-MTD-OPI300
Express Diagnostic Int'l, Inc.
30314
In Commercial Distribution

  • B2983031410 ()
30314

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BUP-MTD-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30314
Not in Commercial Distribution

  • B298303140 ()
30314

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BZO-OPI300-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30313
Not in Commercial Distribution

  • B298303130 ()
30313

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BZO-OPI300-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30312
Not in Commercial Distribution

  • B298303120 ()
30312

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-THC-OPI300
Express Diagnostic Int'l, Inc.
30311
In Commercial Distribution

  • B2983031110 ()
30311

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-THC-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30311
Not in Commercial Distribution

  • B298303110 ()
30311

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-THC-AMP
Express Diagnostic Int'l, Inc.
30310
In Commercial Distribution

  • B2983031010 ()
30310

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

  • B298303100 ()
30310

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, BZO-COC-OPI
EXPRESS DIAGNOSTICS INT'L, INC.
30309
Not in Commercial Distribution

  • B298303090 ()
30309

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC150-OPI300-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30302
Not in Commercial Distribution

  • B298303020 ()
30302

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel Dip Drug Test, COC-THC-MET
Express Diagnostic Int'l, Inc.
30300
In Commercial Distribution

  • B2983030010 ()
30300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BUP-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30212
Not in Commercial Distribution

  • B298302120 ()
30212

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC150-THC
Express Diagnostic Int'l, Inc.
30209
In Commercial Distribution

  • B2983020910 ()
30209

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