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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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iScreen™ - 00817405024018

5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAW105402B
In Commercial Distribution

  • 30817405024019 ()
  • 00817405024018 ()
  • 10817405024015 ()
ABTDOAW105402B

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

iScreen™ - 00817405023509

5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

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

iScreen™ - 00817405023493

5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAK15701A
In Commercial Distribution

  • 30817405023494 ()
  • 00817405023493 ()
  • 10817405023490 ()
ABTDOAK15701A

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

iScreen™ - 00817405023394

5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

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

iScreen™ - 00817405023332

7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50
Instant Technologies, Inc.
ABTDOAW17701A
In Commercial Distribution

  • 30817405023333 ()
  • 00817405023332 ()
  • 10817405023339 ()
ABTDOAW17701A

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

iScreen™ - 00817405023295

5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW15701A
In Commercial Distribution

  • 30817405023296 ()
  • 00817405023295 ()
  • 10817405023292 ()
ABTDUAW15701A

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

iScreen™ - 00817405023264

7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17701A
In Commercial Distribution

  • 30817405023265 ()
  • 00817405023264 ()
  • 10817405023261 ()
ABTDUAW17701A

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

iScreen™ - 00817405023257

6 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW16701A
In Commercial Distribution

  • 30817405023258 ()
  • 00817405023257 ()
  • 10817405023254 ()
ABTDUAW16701A

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

UScreen® - 00817405021239

U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/OXY)
Instant Technologies, Inc.
USSCup-7BO CLIA
In Commercial Distribution

USSCup-7BO CLIA

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

UScreen® - 00817405021161

U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

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

UScreen® - 00817405021130

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCupA-5M
In Commercial Distribution

USSCupA-5M

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

T-Cup® Compact - 00817405021000

T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BZO, COC, MET, MOP, OXY>
Instant Technologies, Inc.
ACDOA-1165
In Commercial Distribution

  • 00817405021000 ()


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

U-Screen - 00817405020973

U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR/SG/OX) 5 Panel Drug Screen (AMP500/BZO300/COC150/MET500/OPI300)
Instant Technologies, Inc.
USSCupA-5E
In Commercial Distribution

  • 00817405020973 ()


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

Accutest - 10763924093639

Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived)
JANT PHARMACAL CORPORATION
DS93S624
In Commercial Distribution

  • 10763924093639 ()
  • 00763924093632 ()
DS93S624

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

Accutest - 10763924084651

Drug Test Cup 5+3 for visual qualitative detection of THC, COC, AMP, MET, OPI2000 with OX, SG, pH adulterant tests
JANT PHARMACAL CORPORATION
DS84S625
In Commercial Distribution

  • 10763924084651 ()
  • 00763924084654 ()
DS84S625

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

Discover Multi-Drug 5 Drugs Rapid Urine Test Cup - 16936983153796

25T, FDA Clia Waived, MOP(OPI)300/COC150/AMP500/MET500/THC50+(OXY/SG/PH)
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983165372 ()
  • 16936983153796 ()


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

U-Catch - 06972428161820

No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161820 ()
BPU255-A3(4)

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

U-Catch - 06972428161806

No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch XR Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161806 ()


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

U-Catch - 06972428161707

No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161707 ()
BPU255-A3(1)

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

U-Catch - 06972428161387

No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch XR Multi-Drug Test Cup
In Commercial Distribution

  • 06972428161387 ()
BXU254

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

Rapid Response - 00722066004883

One Step 5 Panel DOA Cup (5.1.1) - COC150 AMP500 MET500 THC50 MOP2000
BTNX Inc
D5.1.1-1V
In Commercial Distribution

  • 00722066004883 ()


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

Rapid Response - 00722066004814

Rapid Response Multi Drug Test Panel
BTNX Inc
D6.47-1P29-25
In Commercial Distribution

  • 00722066004814 ()
  • 00722066004821 ()


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

Rapid Response - 00722066004524

No Description
BTNX Inc
D5.1-1V
In Commercial Distribution

  • 00722066004524 ()
  • 00722066004531 ()


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

Green GuardInstant Cold Pack - 00347682033026

A device intended to be applied with pressure to the body surface to provide cold therapy - Medium
Greenguard
3302
In Commercial Distribution

  • 50347682033021 ()
  • 00347682033026 ()
3302

  • Endothermic cold therapy pack

Green Guard Instant Cold Pack - 00347682033002

A device intended to be applied with pressure to the body surface to provide cold therapy - large
Greenguard
3300
In Commercial Distribution

  • 50347682033007 ()
  • 00347682033002 ()
3300

  • Endothermic cold therapy pack

CABLE MX-i LED - J00716010690011

Cables are essential accessories meant to connect motors to the Bien-Air pro-prietary consoles or to unit/chairs.
Bien-Air Dental SA
1601069-001
In Commercial Distribution

  • J00716010690011 ()
1601069-001

  • Dental power tool handpiece motorless component

Walgreens - 00311917034218

7 Drugs Tested Home Drug Test - AMP1000COC300/MDMA500/MET1000/OPI2000/PCP25/THC50
WALGREEN CO.
765430
In Commercial Distribution

  • 00311917034218 ()
  • 10311917034215 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

Equate - 00194346098095

EQ 7 PANEL DRUG TEST
WAL-MART STORES, INC.
663495429
In Commercial Distribution

  • 00194346098095 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

DrugConfirm - 00856464008423

7 Drugs Tested Home Drug Test
CONFIRM BIOSCIENCES, INC.
CB-DC-7PanelOTC
In Commercial Distribution

  • 00856464008423 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

Healgen (Private Label) - 684 - 00856464008379

Healgen (DrugConfirm) - 8 Panel Cup Test: AMP1000/COC300/mAMP1000/MDMA500/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-684
In Commercial Distribution

  • 00856464008379 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
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