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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 LEVEL 11 - B800THC11UFWDH0

THC LEVEL 11
UTAK LABORATORIES, INC.
THC 11 U F WDH
In Commercial Distribution

  • B800THC11UFWDH5 ()
  • B800THC11UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 11 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control

THC LEVEL 10 - B800THC10UFWDH0

THC LEVEL 10
UTAK LABORATORIES, INC.
THC 10 U F WDH
In Commercial Distribution

  • B800THC10UFWDH5 ()
  • B800THC10UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 10 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control

Advin Multi-Drug Screen Test - B115ABCARD03061

COC150/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03061 ()
  • B115ABCARD03060 ()
ABCard-03-06

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

Advin Multi-Drug Screen Test - B115ABCARD03031

COC300/MET1000/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03031 ()
  • B115ABCARD03030 ()
ABCard-03-03

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

Advin Multi-Drug Screen Test - B115ABCARD03021

COC150/ME500T/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03021 ()
  • B115ABCARD03020 ()
ABCard-03-02

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

Advin Multi-Drug Screen Test - B115ABCARD03011

AMP/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03011 ()
  • B115ABCARD03010 ()
ABCard-03-01

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

Preview - 00816862021820

THC Single Test
WONDFO USA CO., LTD.
PRE-THC-10BX
In Commercial Distribution

  • 10816862021827 ()
  • 00816862021820 ()
  • 00816862021837 ()


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

DETECTABUSE - 00810042682986

THC 1000ng, 100mL
BIOCHEMICAL DIAGNOSTICS INC
18000454
In Commercial Distribution

  • 00810042682986 ()
18000454

  • Multiple drugs of abuse IVD, control

3-LD Set, PINCH to TWIN, A, 29, TEL COM - 00840828148764

3-LD Set, PINCH to TWIN, A, 29, TEL COM
CURBELL MEDICAL PRODUCTS, INC.
LW-3300029/3AT
In Commercial Distribution

  • 00840828148764 ()
9233

  • Electrocardiographic lead set, reusable

MASEL Buccal Tubes - 00190707102791

BT 022 ROTH COM CV GING UR DB (10)
ORTHO ORGANIZERS, INC.
4016-362-10
In Commercial Distribution

  • 00190707102791 ()


  • Orthodontic tube

MASEL Buccal Tubes - 00190707102784

BT 018 ROTH COM CV GING UL DB (10)
ORTHO ORGANIZERS, INC.
4016-361-10
In Commercial Distribution

  • 00190707102784 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087739

.022 UL6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-363-10
In Commercial Distribution

  • 00190707087739 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087555

.022 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-262-10
In Commercial Distribution

  • 00190707087555 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087722

.018 UR6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-360-10
In Commercial Distribution

  • 00190707087722 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087562

.022 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-263-10
In Commercial Distribution

  • 00190707087562 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087548

.018 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-261-10
In Commercial Distribution

  • 00190707087548 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087531

.018 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-260-10
In Commercial Distribution

  • 00190707087531 ()


  • Orthodontic tube

AMC - 00849593013796

Cable,ECG,Shielded,3 Lead,AAMI,DS com, 10'
Advantage Medical Electronics, LLC
CB-73340R
In Commercial Distribution

  • 00849593013796 ()


  • Electrical-only medical device connection cable, reusable

MEDI - 00636257002575

***DISC*JUXTALITE HD 28 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33024017
Not in Commercial Distribution

  • 00636257002575 ()


  • Compression bandaging kit

MEDI - 00636257002544

***DISC*JUXTALITE HD 33 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33036017
Not in Commercial Distribution

  • 00636257002544 ()


  • Compression bandaging kit

MEDI - 00636257002520

***DISC*JUXTALITE HD 33 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33035017
Not in Commercial Distribution

  • 00636257002520 ()


  • Compression bandaging kit

MEDI - 00636257002506

***DISC*JUXTALITE HD 33 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33034017
Not in Commercial Distribution

  • 00636257002506 ()


  • Compression bandaging kit

MEDI - 00636257002490

***DISC*JUXTALITE HD 33 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33033017
Not in Commercial Distribution

  • 00636257002490 ()


  • Compression bandaging kit

MEDI - 00636257002469

***DISC*JUXTALITE HD 28 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33026017
Not in Commercial Distribution

  • 00636257002469 ()


  • Compression bandaging kit

MEDI - 00636257002445

***DISC*JUXTALITE HD 28 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33025017
Not in Commercial Distribution

  • 00636257002445 ()


  • Compression bandaging kit

MEDI - 00636257002421

***DISC*JUXTALITE HD 28 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33023017
Not in Commercial Distribution

  • 00636257002421 ()


  • Compression bandaging kit

THC Rapid Test Cassette - 00853691007168

THC Rapid Test Cassette
ACRO BIOTECH INC
1
In Commercial Distribution

  • 00853691007168 ()


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

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) - 00857275007124

15 THC test dip-cards
IDUN SOLUTIONS LLC
IDTH-115-15P
Not in Commercial Distribution

  • 00857275007124 ()
  • 00857275007025 ()


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

DrugSmart Dip - 00859144006320

COC/MET1000/THC DipCard
Twin Spirit Inc.
30300D
Not in Commercial Distribution

  • 00859144006320 ()
30300D

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

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

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

THC COOH HYDROLYSIS QC - B800918040

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

  • B800918045 ()
  • B800918040 ()

  • Total Volume: 3 Milliliter
91804

  • Cannabinoid/cannabinoid metabolite 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 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 2 - B800THC2WB2PTFLSA0

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

  • B800THC2WB2PTFLSA5 ()
  • B800THC2WB2PTFLSA0 ()
THC+ 2 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile 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
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