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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X-Cup Positive, Cutoff +50%, 5mL
BIOCHEMICAL DIAGNOSTICS INC
18007797
In Commercial Distribution

  • 00810042680708 ()
18007797

  • Multiple drugs of abuse IVD, control
CHRONOS Positive, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18007772
In Commercial Distribution

  • 00810042680685 ()
18007772

  • Multiple drugs of abuse IVD, control
MDMA/6-MAM, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007716
In Commercial Distribution

  • 00810042680661 ()
18007716

  • Multiple drugs of abuse IVD, control
11 PANEL, 2X Cutoff 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007713
In Commercial Distribution

  • 00810042680654 ()
18007713

  • Multiple drugs of abuse IVD, control
SERIES V with TCA, Cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007701
In Commercial Distribution

  • 00810042680630 ()
18007701

  • Multiple drugs of abuse IVD, control
STAT-SKREEN with MDMA,OXY, BUP, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007664
In Commercial Distribution

  • 00810042680623 ()
18007664

  • Multiple drugs of abuse IVD, control
STAT-SKREEN with MDMA,OXY,BUP, Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007662
In Commercial Distribution

  • 00810042680616 ()
18007662

  • Multiple drugs of abuse IVD, control
STAT-SKREEN with MDMA,OXY,BUP, 3X Cutoff, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007660
In Commercial Distribution

  • 00810042680609 ()
18007660

  • Multiple drugs of abuse IVD, control
MDMA/6-MAM, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007530
In Commercial Distribution

  • 00810042680579 ()
18007530

  • Multiple drugs of abuse IVD, control
CP-UR Panel, Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007525
In Commercial Distribution

  • 00810042680562 ()
18007525

  • Multiple drugs of abuse IVD, control
SSHMOB,2X 2x5ml pack
BIOCHEMICAL DIAGNOSTICS INC
18005144
In Commercial Distribution

  • 00810042680555 ()
18005144

  • Multiple drugs of abuse IVD, control
Negative 2x5ml pack
BIOCHEMICAL DIAGNOSTICS INC
18005143
In Commercial Distribution

  • 00810042680548 ()
18005143

  • Multiple drugs of abuse IVD, control
EUROFINS QC3, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18003278
In Commercial Distribution

  • 00810042680517 ()
18003278

  • Multiple drugs of abuse IVD, control
DOA Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003277
In Commercial Distribution

  • 00810042680500 ()
18003277

  • Multiple drugs of abuse IVD, control
DOA, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18003276
In Commercial Distribution

  • 00810042680494 ()
18003276

  • Multiple drugs of abuse IVD, control
Synthetic Negative with Stabilizer, SG1.003, 1 L
BIOCHEMICAL DIAGNOSTICS INC
18003217
In Commercial Distribution

  • 00810042680487 ()
18003217

  • Multiple drugs of abuse IVD, control
Negative with Stabilizer, SG 1.03, 1L
BIOCHEMICAL DIAGNOSTICS INC
18003216
In Commercial Distribution

  • 00810042680470 ()
18003216

  • Multiple drugs of abuse IVD, control
Negative with Stabilizer, pH9, 1L
BIOCHEMICAL DIAGNOSTICS INC
18003215
In Commercial Distribution

  • 00810042680463 ()
18003215

  • Multiple drugs of abuse IVD, control
Negative with Stabilizer, pH4, 1L
BIOCHEMICAL DIAGNOSTICS INC
18003214
In Commercial Distribution

  • 00810042680456 ()
18003214

  • Multiple drugs of abuse IVD, control
CHRONOS MENU B, +25%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18003209
In Commercial Distribution

  • 00810042680449 ()
18003209

  • Multiple drugs of abuse IVD, control
CHRONOS MENU B, -25%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18003208
In Commercial Distribution

  • 00810042680432 ()
18003208

  • Multiple drugs of abuse IVD, control
Eurofins QC1, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18003093
In Commercial Distribution

  • 00810042680425 ()
18003093

  • Multiple drugs of abuse IVD, control
CHRONOS MENU B, +50%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18003079
In Commercial Distribution

  • 00810042680418 ()
18003079

  • Multiple drugs of abuse IVD, control
CHRONOS MENU B, -50%,20ml
BIOCHEMICAL DIAGNOSTICS INC
18003078
In Commercial Distribution

  • 00810042680401 ()
18003078

  • Multiple drugs of abuse IVD, control
H-Trol 2 5ml
BIOCHEMICAL DIAGNOSTICS INC
18003000
In Commercial Distribution

  • 00810042680364 ()
18003000

  • Multiple drugs of abuse IVD, control
H-Cal 1 5ml
BIOCHEMICAL DIAGNOSTICS INC
18002999
In Commercial Distribution

  • 00810042680357 ()
18002999

  • Multiple drugs of abuse IVD, control
H-Trol 1 5ml
BIOCHEMICAL DIAGNOSTICS INC
18002998
In Commercial Distribution

  • 00810042680340 ()
18002998

  • Multiple drugs of abuse IVD, control
Cobas DAU, Cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18002953
In Commercial Distribution

  • 00810042680302 ()
18002953

  • Multiple drugs of abuse IVD, control
STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control
STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008792
In Commercial Distribution

  • 00810042684430 ()
18008792

  • Multiple drugs of abuse IVD, control
CAL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008791
In Commercial Distribution

  • 00810042684423 ()
18008791

  • Multiple drugs of abuse IVD, control
CAL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008790
In Commercial Distribution

  • 00810042684416 ()
18008790

  • Multiple drugs of abuse IVD, control
Positive QC, 25mL
BIOCHEMICAL DIAGNOSTICS INC
Multitox-PC-25G
In Commercial Distribution

  • 00810042684362 ()
Multitox-PC-25G

  • Multiple drugs of abuse IVD, control
FENTANYL 3ng/mL 2x5mL KITBOX
BIOCHEMICAL DIAGNOSTICS INC
702040
In Commercial Distribution

  • 00810042684355 ()
702040

  • Multiple drugs of abuse IVD, control
NW DOA Panel, +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008623
In Commercial Distribution

  • 00810042684348 ()
18008623

  • Multiple drugs of abuse IVD, control
NW DOA Panel, -25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008622
In Commercial Distribution

  • 00810042684331 ()
18008622

  • Multiple drugs of abuse IVD, control
Cliawaived™ Inc Multitox Urine, POSITIVE QC, 25mL
BIOCHEMICAL DIAGNOSTICS INC
Multitox-PC-25F
In Commercial Distribution

  • 00810042684324 ()
Multitox-PC-25F

  • Multiple drugs of abuse IVD, control
Creatinine 30mg/dL, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481370
In Commercial Distribution

  • 00810042684317 ()
19481370

  • Multiple drugs of abuse IVD, control
Creatinine 10mg/dL, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481360
In Commercial Distribution

  • 00810042684300 ()
19481360

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff +50%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481350
In Commercial Distribution

  • 00810042684294 ()
19481350

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481340
In Commercial Distribution

  • 00810042684287 ()
19481340

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff -30%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481320
In Commercial Distribution

  • 00810042684270 ()
19481320

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff -50%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481310
In Commercial Distribution

  • 00810042684263 ()
19481310

  • Multiple drugs of abuse IVD, control
13 Panel cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008662
In Commercial Distribution

  • 00810042684256 ()
18008662

  • Multiple drugs of abuse IVD, control
13 Panel Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008661
In Commercial Distribution

  • 00810042684249 ()
18008661

  • Multiple drugs of abuse IVD, control
iSCREEN CUP LC 2x10mL Kit
BIOCHEMICAL DIAGNOSTICS INC
88036
In Commercial Distribution

  • 00810042684232 ()
88036

  • Multiple drugs of abuse IVD, control
FOBBMM HIGH 20mL
BIOCHEMICAL DIAGNOSTICS INC
18401100
In Commercial Distribution

  • 00810042684225 ()
18401100

  • Multiple drugs of abuse IVD, control
FOBBMM LOW 20mL
BIOCHEMICAL DIAGNOSTICS INC
18401099
In Commercial Distribution

  • 00810042684218 ()
18401099

  • Multiple drugs of abuse IVD, control
Morphine Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18400043
In Commercial Distribution

  • 00810042684201 ()
18400043

  • Multiple drugs of abuse IVD, control
SSHMOBE with Butalbital 3X cutoff, 5mL
BIOCHEMICAL DIAGNOSTICS INC
18008527
In Commercial Distribution

  • 00810042684195 ()
18008527

  • Multiple drugs of abuse IVD, control
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