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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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THC PLUS LEVEL 3 - B800THC3WB2PTFLSA0

THC PLUS LEVEL 3
UTAK LABORATORIES, INC.
THC+ 3 WB 2PT F LSA
In Commercial Distribution

  • B800THC3WB2PTFLSA5 ()
  • B800THC3WB2PTFLSA0 ()
THC+ 3 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 3 - B800THC3UFWCT0

THC PLUS LEVEL 3
UTAK LABORATORIES, INC.
THC+ 3 U F WCT
In Commercial Distribution

  • B800THC3UFWCT5 ()
  • B800THC3UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 3 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 2 - B800THC2WB2PTFSDHL0

THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 WB 2PT F SDHL
In Commercial Distribution

  • B800THC2WB2PTFSDHL5 ()
  • B800THC2WB2PTFSDHL0 ()

  • Total Volume: 1 Milliliter
THC+ 2 WB 2PT F SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 2 - B800THC2VWBFEPCCO0

THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V WB F EPCCO
In Commercial Distribution

  • B800THC2VWBFEPCCO5 ()
  • B800THC2VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 2 V WB F EPCCO

  • Multiple drugs of abuse IVD, control

THC PLUS LEVEL 2 - B800THC2V2WBNJSP0

THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 WB NJSP
In Commercial Distribution

  • B800THC2V2WBNJSP5 ()
  • B800THC2V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 2 - B800THC2V2UNJSP0

THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 U NJSP
In Commercial Distribution

  • B800THC2V2UNJSP5 ()
  • B800THC2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 2 - B800THC2UFWCT0

THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 U F WCT
In Commercial Distribution

  • B800THC2UFWCT5 ()
  • B800THC2UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 2 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 1 - B800THC1WB2PTFSDHL0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F SDHL
In Commercial Distribution

  • B800THC1WB2PTFSDHL5 ()
  • B800THC1WB2PTFSDHL0 ()

  • Total Volume: 1 Milliliter
THC+ 1 WB 2PT F SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 1 - B800THC1WB2PTFLSA0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F LSA
In Commercial Distribution

  • B800THC1WB2PTFLSA5 ()
  • B800THC1WB2PTFLSA0 ()
THC+ 1 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 1 - B800THC1VWBFEPCCO0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V WB F EPCCO
In Commercial Distribution

  • B800THC1VWBFEPCCO5 ()
  • B800THC1VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 1 V WB F EPCCO

  • Multiple drugs of abuse IVD, control

THC PLUS LEVEL 1 - B800THC1V2WBNJSP0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 WB NJSP
In Commercial Distribution

  • B800THC1V2WBNJSP5 ()
  • B800THC1V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 1 - B800THC1V2UNJSP0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 U NJSP
In Commercial Distribution

  • B800THC1V2UNJSP5 ()
  • B800THC1V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 1 - B800THC1UFWCT0

THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 U F WCT
In Commercial Distribution

  • B800THC1UFWCT5 ()
  • B800THC1UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 1 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

THC 150 NG/ML - B800THC150UPM0

THC 150 NG/ML
UTAK LABORATORIES, INC.
THC 150 U PM
In Commercial Distribution

  • B800THC150UPM5 ()
  • B800THC150UPM0 ()

  • Total Volume: 10 Milliliter
THC 150 U PM

  • Multiple drugs of abuse IVD, control

THC 150 NG/ML - B800THC150UADX0

THC 150 NG/ML
UTAK LABORATORIES, INC.
THC 150 U ADX
In Commercial Distribution

  • B800THC150UADX5 ()
  • B800THC150UADX0 ()

  • Total Volume: 10 Milliliter
THC 150 U ADX

  • Multiple-type clinical chemistry analyte profile IVD, control

THC 1500 NG/ML - B800THC1500UPM0

THC 1500 NG/ML
UTAK LABORATORIES, INC.
THC 1500 U PM
In Commercial Distribution

  • B800THC1500UPM5 ()
  • B800THC1500UPM0 ()

  • Total Volume: 10 Milliliter
THC 1500 U PM

  • Multiple drugs of abuse IVD, control

THC 1500 NG/ML - B800THC1500UADX0

THC 1500 NG/ML
UTAK LABORATORIES, INC.
THC 1500 U ADX
In Commercial Distribution

  • B800THC1500UADX5 ()
  • B800THC1500UADX0 ()

  • Total Volume: 10 Milliliter
THC 1500 U ADX

  • Multiple-type clinical chemistry analyte profile IVD, control

THC PLUS LEVEL 11 - B800THC11UFWCT0

THC PLUS LEVEL 11
UTAK LABORATORIES, INC.
THC+ 11 U F WCT
In Commercial Distribution

  • B800THC11UFWCT5 ()
  • B800THC11UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 11 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control

DAU THC LEVEL 1 - B800DAUTHC1FOL0

DAU THC LEVEL 1
UTAK LABORATORIES, INC.
DAU THC 1 F OL
In Commercial Distribution

  • B800DAUTHC1FOL5 ()
  • B800DAUTHC1FOL0 ()

  • Total Volume: 25 Milliliter
DAU THC 1 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control

THC COOH HYDROLYSIS QC - B80091804TRL0

THC COOH HYDROLYSIS QC
UTAK LABORATORIES, INC.
91804 TRL
In Commercial Distribution

  • B80091804TRL5 ()
  • B80091804TRL0 ()

  • Total Volume: 3 Milliliter
91804 TRL

  • Multiple-type clinical chemistry analyte profile IVD, control

reditest® - 10858904006546

PANEL 02 MAMP500/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020192
In Commercial Distribution

  • 10858904006546 ()
  • 00858904006549 ()
DOA-124-311

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

reditest® - 10858904006539

PANEL 02 COC150/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020191
In Commercial Distribution

  • 10858904006539 ()
  • 00858904006532 ()
DOA-124-201

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

reditest® - 10858904006171

PANEL 2 COC/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020006
In Commercial Distribution

  • 10858904006171 ()
  • 00858904006174 ()
DOA-124-OBC12B

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

Wondfo Drug Test Strip - 00816862025811

1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101
In Commercial Distribution

  • 00816862025811 ()
WDTH-101

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

Wondfo - 00816862023251

1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101-25B
In Commercial Distribution

  • 10816862023258 ()
  • 00816862023251 ()
  • 00816862023268 ()
WDTH-101-25B

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

PrimeScreen - 00816862022278

Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


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

Wondfo Drug Test Strip - 00816862020816

1-Strip; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-101
In Commercial Distribution

  • 10816862020813 ()
  • 00816862020816 ()
  • 00816862029819 ()
WDTH-101

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

PrimeScreen - 00816862022308

Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


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

Immutest Drugs of Abuse Screen Device - 00816565021295

Immutest AMP+MET+THC
AMEDITECH INC.
IMD-3AMJ
Not in Commercial Distribution

  • 00816565021295 ()
IMD-3AMJ

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

ImmuTest Drugs of Abuse Screen Card - 00816565020069

THC single drug dipcard
AMEDITECH INC.
IMD-THC
Not in Commercial Distribution

  • 00816565020069 ()
IMD-THC

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

AICARE - 06970429843110

THC Screen Test Dipcard
Co-Innovation Biotech Co., Ltd
THC Screen Test
Not in Commercial Distribution

  • 26970429843114 ()
  • 06970429843110 ()
  • 16970429843117 ()


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

Dochek - 06974464590091

THC urine test card
Guangzhou Decheng Biotechnology Co., LTD
2551D2X010
Not in Commercial Distribution

  • 06974464590091 ()


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

co-innovation - 06970429840515

Rapid THC Test Dipcard
Co-Innovation Biotech Co., Ltd
THCDIP
In Commercial Distribution

  • 06970429840539 ()
  • 06970429840522 ()
  • 06970429840515 ()


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

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR - 00840828100847

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable

ProScreen - 00858998006852

Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
Instant Tech Subsidiary Acquisition
PSD-6MTDBO300
Not in Commercial Distribution

  • 00858998006852 ()
PSD-6MTDBO300

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

ProScreen - 00817405020737

Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
Instant Technologies, Inc.
PSD-6MTDBO300
Not in Commercial Distribution

  • 00817405020737 ()


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

SMARTABLATE SCom. Recording-/CARTO® Cable - 04260166371352

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m
Stockert GmbH
M490021
In Commercial Distribution

  • 04260166371352 ()


  • Electrical-only medical device connection cable, reusable

SMARTABLATE-SCom. Recording-/CARTO® Cable - 04260166371345

SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m
Stockert GmbH
M490023
In Commercial Distribution

  • 04260166371345 ()


  • Electrical-only medical device connection cable, reusable

OrthoFlex - 00190730002525

OrtFlx Com McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-873
In Commercial Distribution

  • 00190730002525 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002488

OrtFlx Com McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-863
In Commercial Distribution

  • 00190730002488 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002181

OrtFlx Com McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-802
In Commercial Distribution

  • 00190730002181 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002150

OrtFlx Com McLaughlin 018 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-774
In Commercial Distribution

  • 00190730002150 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002105

OrtFlx Com McLaughlin 018 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-763
In Commercial Distribution

  • 00190730002105 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001849

OrtFlx Com McLaughlin 018 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-712
In Commercial Distribution

  • 00190730001849 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000651

Avalon Com McLaughlin 022 LL4 Rx -12° Tor. +2° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-864
Not in Commercial Distribution

  • 00190730000651 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002532

OrtFlx Com McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-874
In Commercial Distribution

  • 00190730002532 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002495

OrtFlx Com McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-864
In Commercial Distribution

  • 00190730002495 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002228

OrtFlx Com McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-812
In Commercial Distribution

  • 00190730002228 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002204

OrtFlx Com McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-811
In Commercial Distribution

  • 00190730002204 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002167

OrtFlx Com McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-801
In Commercial Distribution

  • 00190730002167 ()


  • Orthodontic bracket, plastic, single-use
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