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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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Advin Multi-Drug Screen Test - B115ABCARD10091

AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10091 ()
  • B115ABCARD10090 ()
ABCard-10-09

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

Advin Multi-Drug Screen Test - B115ABCARD10061

AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD10061 ()
  • B115ABCARD10060 ()
ABCard-10-06

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

Oral Fluid Cannabinoid Calibrator, Negative Calibrator - B076S0072C0

15 mL/bottle. Concentration: negative (drug-free) OF THC calibrator buffer.
LIN-ZHI INTERNATIONAL, INC.
S0072c
In Commercial Distribution

  • B076S0072C0 ()
S0072c

  • Cannabinoid/cannabinoid metabolite IVD, calibrator

DrugSmart Dip - 00812203030636

DrugSmart Dip 5, AMP/COC/MET/OPI2000/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30500D
In Commercial Distribution

  • 00812203030636 ()
30500D

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

SureStep™ Urine Test Drug Screen Strip - 00815845024292

SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50)
ALERE SAN DIEGO, INC.
DTH-101
In Commercial Distribution

  • 10815845024299 ()
  • 00815845024292 ()
4561089002

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

OralTox - B313OT807011

7 Panel OralTox - AMP/COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80701
Not in Commercial Distribution

  • B313OT807011 ()
  • B313OT807010 ()


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

DrugCheck - B2987050030

DrugCheck NxScan OnSite Drug Test - AMP/COC/MET/OPI/THC
Express Diagnostic Int'l, Inc.
70500-3
In Commercial Distribution

  • B2987050030 ()
70500-3

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

STATSWABII® - 00816036028587

STATSWABII saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SWABII-158
In Commercial Distribution

  • 00816036029089 ()
  • 00816036028587 ()
SWABII-158

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

STATSWAB® - 00816036028518

STATSWAB saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SSB-158
In Commercial Distribution

  • 00816036029010 ()
  • 00816036028518 ()
SSB-158

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

STATDIP® - 00816036025661

3-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-234-0
In Commercial Distribution

  • 00816036025661 ()
  • 00816036026149 ()
SDP-234-0

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

STATDIP® - 00816036025647

Single STATDIP CLIA WAIVED Dip Card, Marijuana (THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
DTH-114-0
In Commercial Distribution

  • 00816036025647 ()
  • 00816036026125 ()
DTH-114-0

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

STATDIP® - 00816036020048

STAT DOA Single CLIA Waived Test Dipcard, 25Pcs/Box THC
MICRO DISTRIBUTING, L.C
DTH-114
In Commercial Distribution

  • 00816036020048 ()
  • 00816036020437 ()
DTH-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

accutest® - 10763924074423

ACCUTEST MD-9lCOC/AMP/M-AMP/THC/MTD/OPI/PCP/BAR/BZO
JANT PHARMACAL CORPORATION
DS74AC425
In Commercial Distribution

  • 10763924074423 ()
  • 00763924074426 ()


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

accutest® - 10763924060426

accutest MultiDrug Screen 6-panel (AMP/COC/MET/OPI/PCP/THC)
JANT PHARMACAL CORPORATION
DS60AC425
In Commercial Distribution

  • 10763924060426 ()
  • 00763924060429 ()


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

accutest® - 10763924001429

accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)
JANT PHARMACAL CORPORATION
DS01AC425
In Commercial Distribution

  • 10763924001429 ()
  • 00763924001422 ()


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

Easy@Home Multi-Drug Screen Test (25 tests kit) - 00810038631127

25 tests kit;4-Panel Dip Card; COC/THC/OPI/MET
EASY HEALTHCARE CORPORATION
EDOAP-144
In Commercial Distribution

  • 30810038631128 ()
  • 00810038631127 ()
  • 10810038631124 ()
EDOAP-144-25

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

Easy@Home Multi-Drug Test Cup (5 tests kit) - 00810038631110

5 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
ECDOA-254
In Commercial Distribution

  • 30810038631111 ()
  • 00810038631110 ()
  • 10810038631117 ()
ECDOA-254-5

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

Pointe Cannabinoid (THC) Reagent Set - 00811727017253

Pointe Cannabinoid (THC) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.
POINTE SCIENTIFIC, INC.
60-CA0140-1L
In Commercial Distribution

  • 00811727017253 ()
60-CA0140-1L

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Pointe Cannabinoid (THC) Reagent Set - 00811727017246

Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only.
POINTE SCIENTIFIC, INC.
60-CA0140-100
In Commercial Distribution

  • 00811727017246 ()
60-CA0140-100

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

OPI/COC/THC Tests Panel - 06952804801946

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801946 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

CEDIA THC OFT Cutoff Calibrator - 00884883005723

No Description
Microgenics Corporation
10014923
In Commercial Distribution

  • 00884883005723 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator

CEDIA THC OFT Negative Calibrator - 00884883005730

No Description
Microgenics Corporation
10014922
In Commercial Distribution

  • 00884883005730 ()


  • Cannabinoid/cannabinoid metabolite IVD, calibrator

CEDIA THC OFT Controls Kit - 00884883005709

No Description
Microgenics Corporation
10014925
In Commercial Distribution

  • 00884883005709 ()


  • Cannabinoid/cannabinoid metabolite IVD, control

EXPLORO Highly Sensitive THC Test - 06974246461304

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461304 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460970

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
50 tests
In Commercial Distribution

  • 06974246460970 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460963

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
20 tests
In Commercial Distribution

  • 06974246460963 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460956

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
5 tests
In Commercial Distribution

  • 06974246460956 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460949

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
3 tests
In Commercial Distribution

  • 06974246460949 ()
THC50NGML

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

EXPLORO Highly Sensitive THC Test - 06974246460772

No Description
Safecare Biotech (Hangzhou) Co., Ltd.
THC-1011
In Commercial Distribution

  • 06974246460772 ()
THC-1011

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Rapid Response - 00722066003428

Rapid Response Multi Drug Test Panels (AMP/COC/THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D3.14-1P29-25
In Commercial Distribution

  • 00722066003428 ()
  • 00722066003954 ()
D3.14-1P29-25

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

Rapid Response - 00722066000786

Rapid Response Multi Drug Test Panels (MET/COC/THC) - 25 tests/ kit are for the qualitative determination of Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D3.4-1P29-25
In Commercial Distribution

  • 00722066000786 ()
  • 00722066003978 ()
D3.4-1P29-25

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

Rapid Response - 00722066000779

Rapid Response Multi Drug Test Panels (THC/COC/OPI) - 25 tests/ kit are for the qualitative detection of Opiates, Cocaine and THC metabolites in urine.
BTNX Inc
D3.2-1P29-25
In Commercial Distribution

  • 00722066000779 ()
  • 00722066003961 ()
D3.2-1P29-25

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

Generic - 00850019007909

4-Panel DOA Dip Card, COC/THC/MET/AMP, 25 tests/kit
CHEMTRON BIOTECH INC
711D02
In Commercial Distribution

  • 00850019007909 ()


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

DrugSmart Cup 5 - 00850019007664

DrugSmart Cup 5, AMP/COC/OPI/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60505D
In Commercial Distribution

  • 00850019007664 ()


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

DrugSmart Cup - 00850019007480

DrugSmart Cup 6, AMP/COC/THC/OPI2000/MET/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
C60620
In Commercial Distribution

  • 00850019007480 ()
C60620

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

N/A - 00850019007275

3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711C02
In Commercial Distribution

  • 00850019007275 ()
711C02

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

DrugSmart Cup - 00850019007121

DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit
CHEMTRON BIOTECH INC
60620D
In Commercial Distribution

  • 00850019007121 ()
60620D

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

DrugSmart Dip - 00850019007091

DrugSmart Dip 6, AMP/BAR/BZO/COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30620D
In Commercial Distribution

  • 00850019007091 ()
30620D

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

DrugSmart Dip - 00850019007084

DrugSmart Dip 6, AMP/BZO/COC/MET/OPI2000/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30600D
In Commercial Distribution

  • 00850019007084 ()
30600D

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

BluRapids™ - 00850011007020

BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR MM5CPCP
In Commercial Distribution

  • 10850011007027 ()
  • 00850011007020 ()
  • 20850011007024 ()
TNR MM5CPCP

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
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