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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STATCUP II 5 Panel Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATII-6357-0
In Commercial Distribution

  • 00816036025029 ()
  • 00816036025197 ()
STATII-6357-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-1257-0
In Commercial Distribution

  • 00816036025005 ()
  • 00816036025173 ()
STATⅡ-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 Test Cassette, 25Pcs/Box COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SCS-2145
In Commercial Distribution

  • 00816036020383 ()
  • 00816036020772 ()
SCS-2145

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard, 25Pcs/Box COC/mAMP/MDMA/OPI/THC
MICRO DISTRIBUTING, L.C
SDP-1554
In Commercial Distribution

  • 00816036020222 ()
  • 00816036020604 ()
SDP-1554

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard, 25Pcs/Box AMP/COC/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-154
In Commercial Distribution

  • 00816036020185 ()
  • 00816036020567 ()
SDP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 Test Dipcard, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SDP-144
In Commercial Distribution

  • 00816036020178 ()
  • 00816036020550 ()
SDP-144

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 3 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/mAMP/THC
MICRO DISTRIBUTING, L.C
SDP-234
In Commercial Distribution

  • 00816036020161 ()
  • 00816036020543 ()
SDP-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 2 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/THC
MICRO DISTRIBUTING, L.C
SDP-124
In Commercial Distribution

  • 00816036020154 ()
  • 00816036020536 ()
SDP-124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immutest MET+THC Test Card with Cr, Ni, pH, Bl, S.G. adulteration test
AMEDITECH INC.
IMDA-2AMJ
Not in Commercial Distribution

  • 00816565021288 ()
IMDA-2AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0601A-3A
Not in Commercial Distribution

  • 00816565020533 ()
C-C0601A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
KDOA-7104
In Commercial Distribution

  • 10816862020042 ()
  • 00816862020045 ()
  • 00816862029048 ()
KDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
KDOA-3104
In Commercial Distribution

  • 10816862020035 ()
  • 00816862020038 ()
  • 00816862029031 ()
KDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP25 with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0601A-3A
Not in Commercial Distribution

  • 00816555020284 ()
C-C0601A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
KDOA-7104
In Commercial Distribution

  • 00816862025040 ()
KDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
KDOA-3104
In Commercial Distribution

  • 00816862025033 ()
KDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
PRE-PDOA-8105
In Commercial Distribution

  • 00816862021370 ()
  • 00816862028379 ()
  • 10816862021377 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-8104
In Commercial Distribution

  • 10816862021223 ()
  • 00816862021226 ()
  • 00816862028225 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-8104
In Commercial Distribution

  • 10816862026556 ()
  • 00816862026559 ()
  • 00816862026542 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 6-Panel T-Square with indicator: AMP, COC, MET, OPI, PCP, THC
WONDFO USA CO., LTD.
DQODOA-166EUO-I-25BX-A
In Commercial Distribution

  • 10816862024187 ()
  • 00816862024180 ()
  • 00816862024197 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel Card without THC; AMP,BAR,BUP,BZO,COC,MET,MTD,OPI,OXY
WONDFO USA CO., LTD.
WDOA-994NT
In Commercial Distribution

  • 10816862023272 ()
  • 00816862023275 ()
  • 00816862023282 ()
WDOA-994NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Card; AMP/BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/THC/EDDP
WONDFO USA CO., LTD.
WDOA-5114
In Commercial Distribution

  • 10816862023234 ()
  • 00816862023237 ()
  • 00816862023244 ()
WDOA-5114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
CDOA-8105
In Commercial Distribution

  • 00816862021233 ()
  • 00816862028232 ()
  • 10816862021230 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
PRE-PDOA-8104 
In Commercial Distribution

  • 10816862021193 ()
  • 00816862021196 ()
  • 00816862028195 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DDS 5 Test COC 300, MET 1000, OPI 300, TCA 1000, THC 50
SYNTRON BIORESEARCH, INC.
30539
In Commercial Distribution

  • 20748349000360 ()
  • 10748349000363 ()
  • 00748349000366 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461762 ()
THC-1014

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
15 tests
In Commercial Distribution

  • 06974246461755 ()
THC-1014

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Microgenics Corporation
1661060
In Commercial Distribution

  • 00884883004870 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661086
In Commercial Distribution

  • 00884883004863 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661078
In Commercial Distribution

  • 00884883001954 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (125 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0018-5
In Commercial Distribution

  • 00811727017383 ()
60-TH0018-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (62.5 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0016-5
In Commercial Distribution

  • 00811727017352 ()
60-TH0016-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (31.25 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0148-5
In Commercial Distribution

  • 00811727017321 ()
60-TH0148-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Control (18.75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0012-5
In Commercial Distribution

  • 00811727017314 ()
60-TH0012-5

  • Cannabinoid/cannabinoid metabolite IVD, control
Pointe Cannabinoids (THC) Calibrator/Control (37.5 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0014-5
In Commercial Distribution

  • 00811727017291 ()
60-TH0014-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Pointe Cannabinoids (THC) Negative Calibrator (0 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0004-5
In Commercial Distribution

  • 00811727017260 ()
60-TH0004-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/OPI/BZO) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, THC and Cocaine metabolites in urine.
BTNX Inc
D6.1-1P29-25
In Commercial Distribution

  • 00722066000830 ()
  • 00722066004005 ()
D6.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pointe Cannabinoids (THC) Calibrator Control (75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers. The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0152-5
In Commercial Distribution

  • 00811727017338 ()
60-TH0152-5

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral
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