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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AUNZS19 Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100157
In Commercial Distribution

  • 00810042682979 ()
18100157

  • Multiple drugs of abuse IVD, control
AUNZS19 Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100156
In Commercial Distribution

  • 00810042682955 ()
18100156

  • Multiple drugs of abuse IVD, control
SSHMOBE with Butalbital 3X 100mL
BIOCHEMICAL DIAGNOSTICS INC
18008284
In Commercial Distribution

  • 00810042682931 ()
18008284

  • Multiple drugs of abuse IVD, control
Cobas DAU, Cutoff -25%
BIOCHEMICAL DIAGNOSTICS INC
18002952
In Commercial Distribution

  • 00810042682924 ()
18002952

  • Multiple drugs of abuse IVD, control
Detectabuse Custom Liquid Control Serum 5mL
BIOCHEMICAL DIAGNOSTICS INC
Custom QC32
Not in Commercial Distribution

  • 00810042682917 ()


  • Multiple drugs of abuse IVD, control
Salivabuse Custom Liquid Control Oral Fluid 25mL
BIOCHEMICAL DIAGNOSTICS INC
Custom QC29
Not in Commercial Distribution

  • 00810042682887 ()


  • Multiple drugs of abuse IVD, control
STAT-SKREEN Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19470056
In Commercial Distribution

  • 00810042682870 ()
19470056

  • Multiple drugs of abuse IVD, control
CONFIRM 3, Cutoff -25%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
19582025
Not in Commercial Distribution

  • 00810042682863 ()
19582025

  • Multiple drugs of abuse IVD, control
GCMS-H Control, Cutoff -60%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
19572256
In Commercial Distribution

  • 00810042682856 ()
19572256

  • Multiple drugs of abuse IVD, control
SERIES IV-H, Cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19544756
In Commercial Distribution

  • 00810042682849 ()
19544756

  • Multiple drugs of abuse IVD, control
SERIES IV-H, Cutoff -25%, 20 mL
BIOCHEMICAL DIAGNOSTICS INC
19544252
In Commercial Distribution

  • 00810042682832 ()
19544252

  • Multiple drugs of abuse IVD, control
SERIES IX 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19499908
In Commercial Distribution

  • 00810042682825 ()
19499908

  • Multiple drugs of abuse IVD, control
SERIES IX, Cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19499756
In Commercial Distribution

  • 00810042682818 ()
19499756

  • Multiple drugs of abuse IVD, control
SERIES IX, Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19499252
In Commercial Distribution

  • 00810042682801 ()
19499252

  • Multiple drugs of abuse IVD, control
MDMA OXY & BUP, Cutoff +50%, 5mL
BIOCHEMICAL DIAGNOSTICS INC
19470011
In Commercial Distribution

  • 00810042682795 ()
19470011

  • Multiple drugs of abuse IVD, control
MDMA OXY & BUP, Cutoff -50%, 5mL
BIOCHEMICAL DIAGNOSTICS INC
19470010
In Commercial Distribution

  • 00810042682788 ()
19470010

  • Multiple drugs of abuse IVD, control
Combo-A, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003092
In Commercial Distribution

  • 00810042682771 ()
18003092

  • Multiple drugs of abuse IVD, control
Combo-A, Cutoff +50%, 20ml
BIOCHEMICAL DIAGNOSTICS INC
18003091
In Commercial Distribution

  • 00810042682764 ()
18003091

  • Multiple drugs of abuse IVD, control
Combo-A, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003090
In Commercial Distribution

  • 00810042682757 ()
18003090

  • Multiple drugs of abuse IVD, control
Combo-U, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003089
In Commercial Distribution

  • 00810042682740 ()
18003089

  • Multiple drugs of abuse IVD, control
Combo-U, Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003088
In Commercial Distribution

  • 00810042682733 ()
18003088

  • Multiple drugs of abuse IVD, control
Combo-U, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003087
In Commercial Distribution

  • 00810042682726 ()
18003087

  • Multiple drugs of abuse IVD, control
Combo-H, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18002844
In Commercial Distribution

  • 00810042682719 ()
18002844

  • Multiple drugs of abuse IVD, control
Combo-H, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18002842
In Commercial Distribution

  • 00810042682702 ()
18002842

  • Multiple drugs of abuse IVD, control
STATUS DS Positive Control 5mL
BIOCHEMICAL DIAGNOSTICS INC
21000
In Commercial Distribution

  • 00810042682696 ()
210000

  • Multiple drugs of abuse IVD, control
STATUS DS Negative Control 5mL
BIOCHEMICAL DIAGNOSTICS INC
21000
In Commercial Distribution

  • 00810042682689 ()
210000

  • Multiple drugs of abuse IVD, control
ORAL-SKREEN, 3X Cutoff, 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109-6pk
In Commercial Distribution

  • 00810042682658 ()
20200109-6pk

  • Multiple drugs of abuse IVD, control
ORAL-SKREEN NEGATIVE, 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
20200101-6pk
In Commercial Distribution

  • 00810042682641 ()
20200101-6pk

  • Multiple drugs of abuse IVD, control
ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
702030
In Commercial Distribution

  • 00810042682634 ()
702030

  • Multiple drugs of abuse IVD, control
Oral Fluid, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109
In Commercial Distribution

  • 00810042682627 ()
20200109

  • Multiple drugs of abuse IVD, control
Oral Fluid, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200108
In Commercial Distribution

  • 00810042682610 ()
20200108

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200107
In Commercial Distribution

  • 00810042682603 ()
20200107

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200103
In Commercial Distribution

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control
NEGATIVE, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200101
In Commercial Distribution

  • 00810042682580 ()
20200101

  • Multiple drugs of abuse IVD, control
NEGATIVE, 500mL
BIOCHEMICAL DIAGNOSTICS INC
20200100
In Commercial Distribution

  • 00810042682573 ()
20200100

  • Multiple drugs of abuse IVD, control
STAT-SKREEN-H 3X with MDMA, OXY, BUP & EDDP, 100mL
BIOCHEMICAL DIAGNOSTICS INC
18004056
In Commercial Distribution

  • 00810042682566 ()


  • Multiple drugs of abuse IVD, control
Menu CC, CUTOFF +50%
BIOCHEMICAL DIAGNOSTICS INC
18008251
In Commercial Distribution

  • 00810042682559 ()
18008251

  • Multiple drugs of abuse IVD, control
Menu CC, CUTOFF -50%
BIOCHEMICAL DIAGNOSTICS INC
18008250
In Commercial Distribution

  • 00810042682542 ()
18008250

  • Multiple drugs of abuse IVD, control
Menu CB, CUTOFF +50%
BIOCHEMICAL DIAGNOSTICS INC
18008249
In Commercial Distribution

  • 00810042682535 ()
18008249

  • Multiple drugs of abuse IVD, control
Menu CB, CUTOFF -50%
BIOCHEMICAL DIAGNOSTICS INC
18008248
In Commercial Distribution

  • 00810042682528 ()
18008248

  • Multiple drugs of abuse IVD, control
Menu CA, CUTOFF +50%
BIOCHEMICAL DIAGNOSTICS INC
18008247
In Commercial Distribution

  • 00810042682511 ()
18008247

  • Multiple drugs of abuse IVD, control
Menu CA, CUTOFF -50%
BIOCHEMICAL DIAGNOSTICS INC
18008246
In Commercial Distribution

  • 00810042682504 ()
18008246

  • Multiple drugs of abuse IVD, control
DOA SCREEN Cutoff +25% 6x20 mL pk
BIOCHEMICAL DIAGNOSTICS INC
180011V-6pk
In Commercial Distribution

  • 00810042682498 ()
180011V-6pk

  • Multiple drugs of abuse IVD, control
DOA SCREEN Cutoff -25% 6x20 mL pk
BIOCHEMICAL DIAGNOSTICS INC
180010V-6pk
In Commercial Distribution

  • 00810042682481 ()


  • Multiple drugs of abuse IVD, control
SAMPLE APPLICATOR TIPS 500PK
BIOCHEMICAL DIAGNOSTICS INC
17014011
Not in Commercial Distribution

  • 00810042682474 ()
17014011

  • Multiple drugs of abuse IVD, reagent
AUNZS19 Cutoff +50%, 5mL
BIOCHEMICAL DIAGNOSTICS INC
18100154
In Commercial Distribution

  • 00810042682467 ()
18100154

  • Multiple drugs of abuse IVD, control
Multi-Prep GV-65C Natural 15mL, 100pk
BIOCHEMICAL DIAGNOSTICS INC
14300910
Not in Commercial Distribution

  • 00810042682450 ()
14300910

  • Multiple drugs of abuse IVD, reagent
Detectabuse GV-65C 3ML SYR, PKG100
BIOCHEMICAL DIAGNOSTICS INC
14100950
Not in Commercial Distribution

  • 00810042682443 ()
14100950

  • Multiple drugs of abuse IVD, reagent
Detectabuse GV-65 3mL, SYRINGE, 100pK
BIOCHEMICAL DIAGNOSTICS INC
14100720
Not in Commercial Distribution

  • 00810042682436 ()
14100720

  • Multiple drugs of abuse IVD, reagent
Detectabuse GV-65 AMB,15mL,100pk
BIOCHEMICAL DIAGNOSTICS INC
14100620
Not in Commercial Distribution

  • 00810042682429 ()
14100620

  • Multiple drugs of abuse IVD, reagent
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