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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OF 6-MAM, 3X Cutoff, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200004
In Commercial Distribution

  • 00810042683693 ()
18200004

  • Multiple drugs of abuse IVD, control
OF Negative M2, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200180
In Commercial Distribution

  • 00810042683686 ()
18200180

  • Multiple drugs of abuse IVD, control
OF 6-MAM, Cutoff +50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200179
In Commercial Distribution

  • 00810042683679 ()
18200179

  • Multiple drugs of abuse IVD, control
OF 6-MAM, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200178
In Commercial Distribution

  • 00810042683662 ()
18200178

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff +50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200177
In Commercial Distribution

  • 00810042683655 ()
18200177

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200176
In Commercial Distribution

  • 00810042683648 ()
18200176

  • Multiple drugs of abuse IVD, control
HNL DOA cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008256
In Commercial Distribution

  • 00810042683631 ()
18008256

  • Multiple drugs of abuse IVD, control
HNL DOA cutoff-25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008255
In Commercial Distribution

  • 00810042683624 ()
18008255

  • Multiple drugs of abuse IVD, control
Alere Professional cup 2x10 mL kitbox
BIOCHEMICAL DIAGNOSTICS INC
88033
In Commercial Distribution

  • 00810042683617 ()
88033

  • Multiple drugs of abuse IVD, control
Stat-Skreen23H 2x10mL Kitbox
BIOCHEMICAL DIAGNOSTICS INC
702037
In Commercial Distribution

  • 00810042683587 ()
702037

  • Multiple drugs of abuse IVD, control
Stat-Skreen23 2x10mL Kitbox
BIOCHEMICAL DIAGNOSTICS INC
702036
In Commercial Distribution

  • 00810042683570 ()
702036

  • Multiple drugs of abuse IVD, control
Oral-Skreen, M2 NEGATIVE with Stabilizer, 500mL
BIOCHEMICAL DIAGNOSTICS INC
18200007
In Commercial Distribution

  • 00810042683563 ()
18200007

  • Multiple drugs of abuse IVD, control
iScreen™ Urine Drug Screen Controls, Negative and HIGH Positive, 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
88031
In Commercial Distribution

  • 00810042683556 ()
88031

  • Multiple drugs of abuse IVD, control
iScreen™ Urine Drug Screen Controls, Negative and HIGH Positive, 2x5mL
BIOCHEMICAL DIAGNOSTICS INC
88030
In Commercial Distribution

  • 00810042683549 ()
88030

  • Multiple drugs of abuse IVD, control
MDMA 1500ng/mL 20mL
BIOCHEMICAL DIAGNOSTICS INC
18000696
In Commercial Distribution

  • 00810042683532 ()
18000696

  • Multiple drugs of abuse IVD, control
MDMA 250ng/mL, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18000707
In Commercial Distribution

  • 00810042683525 ()
18000707

  • Multiple drugs of abuse IVD, control
iScreen™ Urine Drug Screen Controls, Negative and Cotinine Positive, 2x5mL kitbox
BIOCHEMICAL DIAGNOSTICS INC
88006
In Commercial Distribution

  • 00810042683501 ()
88006

  • Multiple drugs of abuse IVD, control
SSHMOBE Cutoff -50% , 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001383
In Commercial Distribution

  • 00810042683464 ()
18001383

  • Multiple drugs of abuse IVD, control
SSHMOBE Cutoff +50% , 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001386
In Commercial Distribution

  • 00810042683457 ()
18001386

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CC +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008474
In Commercial Distribution

  • 00810042683440 ()
18008474

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CC -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008473
In Commercial Distribution

  • 00810042683433 ()
18008473

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CB +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008472
In Commercial Distribution

  • 00810042683426 ()
18008472

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CB -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008471
In Commercial Distribution

  • 00810042683419 ()
18008471

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008470
In Commercial Distribution

  • 00810042683402 ()
18008470

  • Multiple drugs of abuse IVD, control
Menu CC, Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008468
In Commercial Distribution

  • 00810042683396 ()
18008468

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008469
In Commercial Distribution

  • 00810042683389 ()
18008469

  • Multiple drugs of abuse IVD, control
Menu CC, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008467
In Commercial Distribution

  • 00810042683372 ()
18008467

  • Multiple drugs of abuse IVD, control
Menu CB Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008466
In Commercial Distribution

  • 00810042683365 ()
18008466

  • Multiple drugs of abuse IVD, control
Menu CA Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008464
In Commercial Distribution

  • 00810042683358 ()
18008464

  • Multiple drugs of abuse IVD, control
Menu CB Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008465
In Commercial Distribution

  • 00810042683341 ()
18008465

  • Multiple drugs of abuse IVD, control
Menu CA Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008463
In Commercial Distribution

  • 00810042683334 ()
18008463

  • Multiple drugs of abuse IVD, control
Detectabuse Custom Liquid Control 10x50mL pack
BIOCHEMICAL DIAGNOSTICS INC
Custom QC33
Not in Commercial Distribution

  • 00810042683327 ()


  • Multiple drugs of abuse IVD, control
Stability Control, Menu CB -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008422
In Commercial Distribution

  • 00810042683310 ()
18008422

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CC +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008425
In Commercial Distribution

  • 00810042683303 ()
18008425

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CC -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008424
In Commercial Distribution

  • 00810042683297 ()
18008424

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CB +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008423
In Commercial Distribution

  • 00810042683280 ()
18008423

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008421
In Commercial Distribution

  • 00810042683273 ()
18008421

  • Multiple drugs of abuse IVD, control
Stability Control, Menu CA -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008420
In Commercial Distribution

  • 00810042683266 ()


  • Multiple drugs of abuse IVD, control
Specialty Diagnostix QC Low/High, 2x20mL Kitbox
BIOCHEMICAL DIAGNOSTICS INC
18008449
In Commercial Distribution

  • 00810042683259 ()


  • Multiple drugs of abuse IVD, control
SSHMOBE with Butalbital Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008327
In Commercial Distribution

  • 00810042683242 ()


  • Multiple drugs of abuse IVD, control
SSHMOBE with Butalbital Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18002824
In Commercial Distribution

  • 00810042683235 ()


  • Multiple drugs of abuse IVD, control
CSCQ Specimen 4
BIOCHEMICAL DIAGNOSTICS INC
18008448
In Commercial Distribution

  • 00810042683228 ()


  • Multiple drugs of abuse IVD, control
CSCQ Specimen 3
BIOCHEMICAL DIAGNOSTICS INC
18008447
In Commercial Distribution

  • 00810042683211 ()


  • Multiple drugs of abuse IVD, control
CSCQ Specimen 2
BIOCHEMICAL DIAGNOSTICS INC
18008446
In Commercial Distribution

  • 00810042683204 ()


  • Multiple drugs of abuse IVD, control
CSCQ Specimen 1
BIOCHEMICAL DIAGNOSTICS INC
18008445
In Commercial Distribution

  • 00810042683198 ()


  • Multiple drugs of abuse IVD, control
DOA Liquid Control Urine (2x10mL Kitbox)
BIOCHEMICAL DIAGNOSTICS INC
CD-DOACTLS10
In Commercial Distribution

  • 00810042683143 ()
CD-DOACTLS10

  • Multiple drugs of abuse IVD, control
BIO-TROL, Level N5 Positive, 10x5mL Pack
BIOCHEMICAL DIAGNOSTICS INC
BIO-N5
Not in Commercial Distribution

  • 00810042683082 ()
BIO-N5

  • Multiple drugs of abuse IVD, control
SSHMOBE with Butalbital 2x20mL Kit
BIOCHEMICAL DIAGNOSTICS INC
820001
In Commercial Distribution

  • 00810042683075 ()
820001

  • Multiple drugs of abuse IVD, control
BIO-TROL, Level P3 Positive, 10x5mL Pack
BIOCHEMICAL DIAGNOSTICS INC
BIO-P3
Not in Commercial Distribution

  • 00810042683068 ()
BIO-P3

  • Multiple drugs of abuse IVD, control
SYNTHETIC Negative Urine with Stabilizer, Normal pH ,SG 1.003, No Creatinine, 200mL
BIOCHEMICAL DIAGNOSTICS INC
18008334
In Commercial Distribution

  • 00810042683051 ()
18008334

  • Multiple drugs of abuse IVD, control
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