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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CP-OF Panel, 3X, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100151
In Commercial Distribution

  • 00810042681149 ()
18100151

  • Multiple drugs of abuse IVD, control
CP-OF Panel, +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100150
In Commercial Distribution

  • 00810042681132 ()
18100150

  • Multiple drugs of abuse IVD, control
CP-OF Panel, -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100149
In Commercial Distribution

  • 00810042681125 ()
18100149

  • Multiple drugs of abuse IVD, control
Custom Oral Fluid, AU/NZ, Cutoff +50%, 5mL
BIOCHEMICAL DIAGNOSTICS INC
18100001
In Commercial Distribution

  • 00810042681118 ()
18100001

  • Multiple drugs of abuse IVD, control
MultiTox Negative, 25mL Cliawaived
BIOCHEMICAL DIAGNOSTICS INC
MULTITOX-NC-25
In Commercial Distribution

  • 00810042681057 ()
MULTITOX-NC-25

  • Multiple drugs of abuse IVD, control
BIO-TROL, LEVEL N Negative 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
BIO-N 6x20mL
Not in Commercial Distribution

  • 00810042681033 ()
BIO-N

  • Multiple drugs of abuse IVD, control
iScreen Negative, 20mL
BIOCHEMICAL DIAGNOSTICS INC
88002
Not in Commercial Distribution

  • 00810042680982 ()


  • Multiple drugs of abuse IVD, control
iScreen Negative, 5mL
BIOCHEMICAL DIAGNOSTICS INC
88000
Not in Commercial Distribution

  • 00810042680968 ()
88000

  • Multiple drugs of abuse IVD, control
Custom Oral Fluid, Negative, 5mL
BIOCHEMICAL DIAGNOSTICS INC
18100000
In Commercial Distribution

  • 00810042681101 ()
18100000

  • Multiple drugs of abuse IVD, control
MultiTox Positive, 25mL Cliawaived PosQC
BIOCHEMICAL DIAGNOSTICS INC
MULTITOX-PC-25E
In Commercial Distribution

  • 00810042681064 ()
MULTITOX-PC-25E

  • Multiple drugs of abuse IVD, control
BIO-TROL, LEVEL P2 Positive 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
BIO-P2 6x20mL
Not in Commercial Distribution

  • 00810042681040 ()
BIO-P2

  • Multiple drugs of abuse IVD, control
Alere Professional cup 10 mL kitbox
BIOCHEMICAL DIAGNOSTICS INC
88010
Not in Commercial Distribution

  • 00810042681026 ()
88010

  • Multiple drugs of abuse IVD, control
iSCREEN 20mL Kitbox
BIOCHEMICAL DIAGNOSTICS INC
88005
Not in Commercial Distribution

  • 00810042681019 ()
88005

  • Multiple drugs of abuse IVD, control
Alere iScreen kitbox,5mL
BIOCHEMICAL DIAGNOSTICS INC
88004
Not in Commercial Distribution

  • 00810042681002 ()
88004

  • Multiple drugs of abuse IVD, control
iScreen Positive, 20mL
BIOCHEMICAL DIAGNOSTICS INC
88003
Not in Commercial Distribution

  • 00810042680999 ()
88003

  • Multiple drugs of abuse IVD, control
iScreen Positive, 5mL
BIOCHEMICAL DIAGNOSTICS INC
88001
Not in Commercial Distribution

  • 00810042680975 ()
88001

  • Multiple drugs of abuse IVD, control
Stat-Skreen (LM) with MDMA, Oxy, Bup, kitbox 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
820000
In Commercial Distribution

  • 00810042680951 ()
820000

  • Multiple drugs of abuse IVD, control
Triage DOA Control 2, Positive. 6X 5mL
BIOCHEMICAL DIAGNOSTICS INC
52230
In Commercial Distribution

  • 00810042680937 ()
52230

  • Multiple drugs of abuse IVD, control
Triage NEGATIVE 6 X 5mL
BIOCHEMICAL DIAGNOSTICS INC
52229
In Commercial Distribution

  • 00810042680920 ()
52229

  • Multiple drugs of abuse IVD, control
Drug Evaluation Panel, #1-20, 3mL
BIOCHEMICAL DIAGNOSTICS INC
26657
In Commercial Distribution

  • 00810042680913 ()
26657

  • Multiple drugs of abuse IVD, control
DOA Positive
BIOCHEMICAL DIAGNOSTICS INC
18030395
In Commercial Distribution

  • 00810042680807 ()
18030395

  • Multiple drugs of abuse IVD, control
DOA Negative
BIOCHEMICAL DIAGNOSTICS INC
18030394
In Commercial Distribution

  • 00810042680791 ()
18030394

  • Multiple drugs of abuse IVD, control
CHRONOS MENU A, +25%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18030393
In Commercial Distribution

  • 00810042680784 ()
18030393

  • Multiple drugs of abuse IVD, control
CHRONOS MENU A, -25%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18030392
In Commercial Distribution

  • 00810042680777 ()
18030392

  • Multiple drugs of abuse IVD, control
CHRONOS MENU A, +50%, 20ml
BIOCHEMICAL DIAGNOSTICS INC
18030391
In Commercial Distribution

  • 00810042680760 ()
18030391

  • Multiple drugs of abuse IVD, control
CHRONOS MENU A, -50%, 20ml
BIOCHEMICAL DIAGNOSTICS INC
18030390
In Commercial Distribution

  • 00810042680753 ()
18030390

  • Multiple drugs of abuse IVD, control
OPIOID HIGH, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18030363
In Commercial Distribution

  • 00810042680739 ()
18030363

  • Multiple drugs of abuse IVD, control
OPIOID LOW, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18030362
In Commercial Distribution

  • 00810042680722 ()
18030362

  • Multiple drugs of abuse IVD, control
Status DS Control Set (Neg&Pos 2.5 ml)
PRINCETON BIOMEDITECH CORPORATION
21000
In Commercial Distribution

  • 10743816001546 ()


  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Drug Free Urine Control
Beckman Coulter, Inc.
469945
In Commercial Distribution

  • 15099590180225 ()
469945

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Negative Urine Calibrator
Beckman Coulter, Inc.
445803
In Commercial Distribution

  • 15099590230517 ()
445803

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON Systems DAT Multi-Drug Low Urine Control
Beckman Coulter, Inc.
474976
In Commercial Distribution

  • 15099590223328 ()
474976

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug High Urine Control
Beckman Coulter, Inc.
474979
In Commercial Distribution

  • 15099590223311 ()
474979

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator
Beckman Coulter, Inc.
474970
In Commercial Distribution

  • 15099590223298 ()
474970

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON System DAT Multi-Drug High Urine Calibrator
Beckman Coulter, Inc.
474973
In Commercial Distribution

  • 15099590223281 ()
474973

  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1594
In Commercial Distribution

  • 00884883011571 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1815326
In Commercial Distribution

  • 00884883011557 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1597
In Commercial Distribution

  • 00884883011502 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1557416
In Commercial Distribution

  • 00884883011489 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1588
In Commercial Distribution

  • 00884883011458 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
10014954
In Commercial Distribution

  • 00884883011045 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
10014955
In Commercial Distribution

  • 00884883011038 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
10014957
In Commercial Distribution

  • 00884883010987 ()


  • Multiple drugs of abuse IVD, control
No Description
Microgenics Corporation
1388
In Commercial Distribution

  • 00884883005969 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
100033
In Commercial Distribution

  • 00884883005914 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1598
In Commercial Distribution

  • 00884883005235 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1595
In Commercial Distribution

  • 00884883005228 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1592
In Commercial Distribution

  • 00884883005211 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
1589
In Commercial Distribution

  • 00884883005143 ()


  • Multiple drugs of abuse IVD, calibrator
No Description
Microgenics Corporation
100122
In Commercial Distribution

  • 00884883005112 ()


  • Multiple drugs of abuse IVD, calibrator
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