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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PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/P CP/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020183
In Commercial Distribution

  • 10858904006409 ()
  • 00858904006402 ()
DOA-1104-751

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-184-RCN
In Commercial Distribution

  • 10850721007034 ()
  • 00850721007037 ()
  • 20850721007031 ()
U-CUP-184-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Drug Test Card BZO/COC/THC/mAMP/MOP/MTD/OXY/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-DOA-394
In Commercial Distribution

  • 10850721007010 ()
  • 00850721007013 ()
  • 20850721007017 ()
U-DOA-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Drug Test Card BZO/BAR/COC/mAMP/MOP/MTD/OXY/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-DOA-294
In Commercial Distribution

  • 10850721007003 ()
  • 00850721007006 ()
  • 20850721007000 ()
U-DOA-294

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
T2 BIOSYSTEMS, INC.
80-08072
In Commercial Distribution

  • M70880080720 ()
  • M70880080723 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
80-07342
In Commercial Distribution

  • M70880073423 ()
  • M70880050580 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, reagent
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
80-01689
In Commercial Distribution

  • M70880016893 ()
  • M70880009660 ()


  • Multiple Candida species nucleic acid IVD, reagent
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
IDUN SOLUTIONS LLC
41511104001034
In Commercial Distribution

  • 90857275007837 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Control Panel
MICROBIOLOGICS INC.
8242
In Commercial Distribution

  • 70845357044180 ()
8242

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel
MICROBIOLOGICS INC.
8249
In Commercial Distribution

  • 70845357043732 ()
8249

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8246
In Commercial Distribution

  • 70845357043602 ()
8246

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8236
In Commercial Distribution

  • 70845357043060 ()
8236

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory (4 Targets) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8233
Not in Commercial Distribution

  • 70845357042742 ()
8233

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inactivated)
MICROBIOLOGICS INC.
8201
Not in Commercial Distribution

  • 70845357041486 ()
8201

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8181
In Commercial Distribution

  • 70845357041431 ()
8181

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8180
In Commercial Distribution

  • 70845357041424 ()
8180

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8189
In Commercial Distribution

  • 70845357041196 ()
8189

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8187
In Commercial Distribution

  • 70845357041172 ()
8187

  • Multiple bacteria carbapenemase nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Control Panel (Inactivated)
MICROBIOLOGICS INC.
8215
Not in Commercial Distribution

  • 70845357041165 ()
8215

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification (BCID) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5229P
Not in Commercial Distribution

  • 70845357038899 ()
5229P

  • Multiple bacteria species culture isolate identification control IVD, kit
U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET).
Instant Technologies, Inc.
USSCup-4NT
In Commercial Distribution

USSCup-4NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 4 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP
MICRO DISTRIBUTING, L.C
STATII-0247-0
In Commercial Distribution

  • 00816036025487 ()
  • 00816036025470 ()
STATII-0247-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0
In Commercial Distribution

  • 00816036025036 ()
  • 00816036025203 ()
STATⅡ-2167-3-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 panel test cup, COC/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-2P
Not in Commercial Distribution

  • 00816565020182 ()
IMCA-2P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-3124A3
In Commercial Distribution

  • 20816490021838 ()
  • 10816490021831 ()
  • 00816490021834 ()
HCDOAV-3124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-2145A3
In Commercial Distribution

  • 20816490020985 ()
  • 10816490020988 ()
  • 00816490020981 ()
HCDOAV-2145A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Round Cup With Clicker; +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-2135A3
In Commercial Distribution

  • 20816490020923 ()
  • 10816490020926 ()
  • 00816490020929 ()
HCDOAV-2135A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Round Cup With Clicker +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-264A3
In Commercial Distribution

  • 20816490020916 ()
  • 10816490020919 ()
  • 00816490020912 ()
HCDOAV-264A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-274A3
In Commercial Distribution

  • 20816490020886 ()
  • 10816490020889 ()
  • 00816490020882 ()
HCDOAV-274A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-3104A3
In Commercial Distribution

  • 20816490020749 ()
  • 10816490020742 ()
  • 00816490020745 ()
HCDOAV-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Round Cup +3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-8105A3
In Commercial Distribution

  • 20816490023610 ()
  • 10816490023613 ()
  • 00816490023616 ()
HCDOAV-8105A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsCRE/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-6125SA3A
In Commercial Distribution

  • 20816490022002 ()
  • 10816490022005 ()
  • 00816490022008 ()
HCDOAV-6125SA3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;+ Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-4124A3
In Commercial Distribution

  • 20816490021746 ()
  • 10816490021749 ()
  • 00816490021742 ()
HCDOAV-4124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-1104SA3
In Commercial Distribution

  • 20816490021678 ()
  • 10816490021671 ()
  • 00816490021674 ()
HCDOAV-1104SA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-4125A3
In Commercial Distribution

  • 20816490021494 ()
  • 10816490021497 ()
  • 00816490021490 ()
HCDOAV-4125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-454A3
In Commercial Distribution

  • 20816490021395 ()
  • 10816490021398 ()
  • 00816490021391 ()
HCDOAV-454A3

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