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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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
5 Panel DOA Test Clear Round Cup +3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-254A3
In Commercial Distribution

  • 20816490020848 ()
  • 10816490020841 ()
  • 00816490020844 ()
HCDOAV-254A3

  • 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-7104A3
In Commercial Distribution

  • 20816490020770 ()
  • 10816490020773 ()
  • 00816490020776 ()
HCDOAV-7104A3

  • 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
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
5 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-154A3
In Commercial Distribution

  • 20816490021364 ()
  • 10816490021367 ()
  • 00816490021360 ()
HCDOAV-154A3

  • 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-6125SA3
In Commercial Distribution

  • 20816490021340 ()
  • 10816490021343 ()
  • 00816490021346 ()
HCDOAV-6125SA3

  • 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-654A3
In Commercial Distribution

  • 20816490021302 ()
  • 10816490021305 ()
  • 00816490021308 ()
HCDOAV-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test Clear Round Cup +3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-274A3
In Commercial Distribution

  • 20816490021067 ()
  • 10816490021060 ()
  • 00816490021063 ()
HCDOA-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-4104A3
In Commercial Distribution

  • 20816490020732 ()
  • 10816490020735 ()
  • 00816490020738 ()
HCDOAV-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Flu A/Flu B/SARS-CoV-2 Control Panel
MICROBIOLOGICS INC.
CL00016
In Commercial Distribution

  • 80845357044415 ()
CL00016

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit
MICROBIOLOGICS INC.
8246-SPL
In Commercial Distribution

  • 70845357044388 ()
8246-SPL

  • Multiple-genus respiratory virus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel
MICROBIOLOGICS INC.
8258
In Commercial Distribution

  • 70845357044197 ()
8258

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
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™ CT/GC/TV Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8228
In Commercial Distribution

  • 70845357042681 ()
8228

  • Multiple-type sexually transmitted pathogen 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
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