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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QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC043
Not in Commercial Distribution

  • 01812125010074 ()
AC043

  • Specimen processing instrument IVD
Home Drug Test 7 Panel THC/COC/OPI/PCP/mAMP/AMP/MDMA
RITE AID CORPORATION
8024511
In Commercial Distribution

  • 00011822001694 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
6 Panel Masked EUO Oral Fluid AMP50, THC40, OXY20, COC20, MET50, OPI40
Instant Technologies, Inc.
ABTOFCUBE0605E
In Commercial Distribution

  • 30817405024064 ()
  • 00817405024063 ()
  • 10817405024060 ()
ABTOFCUBE0605E

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAW105402B
In Commercial Distribution

  • 30817405024019 ()
  • 00817405024018 ()
  • 10817405024015 ()
ABTDOAW105402B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel CLIA Waived Urine Dip Card AMP1000, COC300,OPI2000,PCP25,THC50
Instant Technologies, Inc.
ABTDOAW105401A
In Commercial Distribution

  • 30817405024002 ()
  • 00817405024001 ()
  • 10817405024008 ()
ABTDOAW105401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10
Instant Technologies, Inc.
ABTOFCUBE0603C
In Commercial Distribution

  • 30817405023548 ()
  • 00817405023547 ()
  • 10817405023544 ()
ABTOFCUBE0603C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0602B
In Commercial Distribution

  • 30817405023531 ()
  • 00817405023530 ()
  • 10817405023537 ()
ABTOFCUBE0602B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 PANEL E&I OF CUBE AMP50/BAR20/COC20/OPI40/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0601A
In Commercial Distribution

  • 30817405023524 ()
  • 00817405023523 ()
  • 10817405023520 ()
ABTOFCUBE0601A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Pneumonia (33 Targets) Control Panel
MICROBIOLOGICS INC.
8244
Not in Commercial Distribution

  • 70845357043664 ()
8244

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
MICROBIOLOGICS INC.
8247
In Commercial Distribution

  • 70845357043619 ()
8247

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory (21 Targets) Control Panel
MICROBIOLOGICS INC.
8217
Not in Commercial Distribution

  • 70845357042506 ()
8217

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8205
In Commercial Distribution

  • 70845357041400 ()
8205

  • Norovirus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)
MICROBIOLOGICS INC.
8182
Not in Commercial Distribution

  • 70845357041356 ()
8182

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Verification Panel
MICROBIOLOGICS INC.
8216
Not in Commercial Distribution

  • 70845357041134 ()
8216

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Control Panel
MICROBIOLOGICS INC.
8214
Not in Commercial Distribution

  • 70845357041127 ()
8214

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Enteric Bacterial Verification Panel (Live Culture)
MICROBIOLOGICS INC.
8179
In Commercial Distribution

  • 70845357036635 ()
8179

  • Multiple bacteria species culture isolate identification control IVD, kit
10 Panel DOA Test clear Cup;+Adulterant Test Strips CR/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-8105A3A
In Commercial Distribution

  • 20816490023108 ()
  • 10816490023101 ()
  • 00816490023104 ()
HCDOAEW-8105A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup;+Adulterant Test Strips CR/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-6125A3A
In Commercial Distribution

  • 20816490023078 ()
  • 10816490023071 ()
  • 00816490023074 ()
HCDOAEW-6125A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, BZO/COC/mAMP/MOR/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0
In Commercial Distribution

  • 00816036027146 ()
  • 00816036026644 ()
SCP-6157-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, COC/mAMP/OPI/PCP/THC , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0
In Commercial Distribution

  • 00816036026521 ()
  • 00816036027023 ()
SCP-3257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-1257-0
In Commercial Distribution

  • 00816036026507 ()
  • 00816036027009 ()
SCP-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZO+BUP+MET1000+MTD+OPI300
AMEDITECH INC.
IMC-8BB
Not in Commercial Distribution

  • 00816565020175 ()
IMC-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-6124A3
In Commercial Distribution

  • 20816490021968 ()
  • 10816490021961 ()
  • 00816490021964 ()
HCDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup + Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAF-6125A3
In Commercial Distribution

  • 20816490021425 ()
  • 10816490021428 ()
  • 00816490021421 ()
HCDOAF-6125A3

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

  • 20816490021227 ()
  • 10816490021220 ()
  • 00816490021223 ()
HCDOA-8105A3

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

  • 20816490021203 ()
  • 10816490021206 ()
  • 00816490021209 ()
HCDOA-1104SA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup ;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOA-254A3
In Commercial Distribution

  • 20816490021180 ()
  • 10816490021183 ()
  • 00816490021186 ()
HCDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Flat Cup + Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAF-254A3
In Commercial Distribution

  • 20816490020695 ()
  • 10816490020698 ()
  • 00816490020691 ()
HCDOAF-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
MX50YQS
In Commercial Distribution

  • 08809241513087 ()


  • Image display unit, colour
Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)
WIDE corporation
CX50YQS
In Commercial Distribution

  • 08809241513070 ()


  • Image display unit, colour
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