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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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QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8234
In Commercial Distribution

  • 70845357043077 ()
8234

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8206
In Commercial Distribution

  • 70845357042810 ()
8206

  • Multiple Mycobacterium species nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory Pathogens (16 Strains) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8198
Not in Commercial Distribution

  • 70845357041455 ()
8198

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8203
In Commercial Distribution

  • 70845357041387 ()
8203

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel E&I Oral Click Cube AMP50, BAR50, COC20, MDMA50, MET50, MTD30, OPI40, OXY20
Instant Technologies, Inc.
ABTOFCUBE0801A
In Commercial Distribution

  • 30817405023920 ()
  • 00817405023929 ()
  • 10817405023926 ()
ABTOFCUBE0801A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10
Instant Technologies, Inc.
ABTOFCUBE0901A
In Commercial Distribution

  • 30817405023562 ()
  • 00817405023561 ()
  • 10817405023568 ()
ABTOFCUBE0901A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP
MICRO DISTRIBUTING, L.C
STATII-0257-0
In Commercial Distribution

  • 00816036025364 ()
  • 00816036025371 ()
STATII-0257-0

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

  • 00816036026583 ()
  • 00816036027085 ()
SCP-2167-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Phototherapy Unit. UVB Narrowband. Single upright panel with 8 lamps. Mounts to wall or stand.
Medtek Lighting Corporation
80B
In Commercial Distribution

  • B343B80 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 170 Pound
80B

  • Ultraviolet phototherapy unit, professional
Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall.
Medtek Lighting Corporation
20B
In Commercial Distribution

  • B343B20 ()

  • Area/Surface Area: 621 Square inch
  • Weight: 40 Pound
20B

  • Ultraviolet phototherapy unit, professional
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 25 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-25BX
In Commercial Distribution

  • 10816862026136 ()
  • 00816862026139 ()
  • 00816862026122 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-10BX
In Commercial Distribution

  • 10816862026112 ()
  • 00816862026115 ()
  • 00816862026108 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 5 Test/Box
WONDFO USA CO., LTD.
DWFTY-OTC1-5BX
In Commercial Distribution

  • 10816862026099 ()
  • 00816862026092 ()
  • 00816862026085 ()


  • Fentanyl IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-3P
Not in Commercial Distribution

  • 00816565020199 ()
IMCA-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test Strips CRE/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-5125A3A
In Commercial Distribution

  • 20816490021753 ()
  • 10816490021756 ()
  • 00816490021759 ()
HCDOAV-5125A3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
Healgen Scientific Limited Liability Company
HCDOAF-5114A6
In Commercial Distribution

  • 20816490021692 ()
  • 10816490021695 ()
  • 00816490021698 ()
HCDOAF-5114A6

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