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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Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
MICROBIOLOGICS INC.
HE0025S
Not in Commercial Distribution

  • 10845357041965 ()
HE0025S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
MICROBIOLOGICS INC.
HE0015S
Not in Commercial Distribution

  • 10845357041873 ()
HE0015S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
MICROBIOLOGICS INC.
HE0013S
In Commercial Distribution

  • 10845357041859 ()
HE0013S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
MICROBIOLOGICS INC.
HE0012S
In Commercial Distribution

  • 10845357041842 ()
HE0012S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
MICROBIOLOGICS INC.
HE0007S
Not in Commercial Distribution

  • 10845357041798 ()
HE0007S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
MICROBIOLOGICS INC.
HE0006S
Not in Commercial Distribution

  • 10845357041781 ()
HE0006S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA
MICROBIOLOGICS INC.
HE0005S
Not in Commercial Distribution

  • 10845357041774 ()
HE0005S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA
MICROBIOLOGICS INC.
HE0004S
Not in Commercial Distribution

  • 10845357041767 ()
HE0004S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
MICROBIOLOGICS INC.
HE0003S
Not in Commercial Distribution

  • 10845357041750 ()
HE0003S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
MICROBIOLOGICS INC.
HE0002S
Not in Commercial Distribution

  • 10845357041743 ()
HE0002S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
MICROBIOLOGICS INC.
HE0001S
Not in Commercial Distribution

  • 10845357041736 ()
HE0001S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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™ Enteric Parasite Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8230
In Commercial Distribution

  • 70845357042698 ()
8230

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution

  • 70845357041448 ()
8184

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
BD MAX™ Enteric Parasite Control Panel
MICROBIOLOGICS INC.
8204 BD MAX™ Enteric Parasite Control Panel
In Commercial Distribution

  • 70845357041394 ()
8204

  • Multiple-type gastrointestinal pathogen 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™ Enteric Viral Control Panel
MICROBIOLOGICS INC.
8211
In Commercial Distribution

  • 70845357041158 ()
8211

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-001
In Commercial Distribution

  • 16971554725019 ()
  • 06971554725012 ()
DE-001

  • Needle guide, single-use
NEVI SCALER POSTERIOR D/E, #7 HDL
HU-FRIEDY MFG. CO., LLC
SCNEVI27
In Commercial Distribution

  • 10889950025328 ()


  • Manual dental scaler, reusable
NEVI SCALER ANTERIOR D/E #7 Hdl
HU-FRIEDY MFG. CO., LLC
SCNEVI17
In Commercial Distribution

  • 10889950025250 ()


  • Manual dental scaler, reusable
NEVI Scaler Anterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI1
In Commercial Distribution

  • 10889950025243 ()


  • Manual dental scaler, reusable
NEVI Scaler Posterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI2
In Commercial Distribution

  • 10889950025311 ()


  • Manual dental scaler, reusable
PB215-E (Medium Clip Applier, 15cm, E Etched)
VITALITEC INTERNATIONAL, INC.
PB215-E
In Commercial Distribution

  • 00857987006804 ()

  • Length: 15 Centimeter


  • Open-surgery ligation clip applier
PO428-E (Large Clip Applier, 28cm E Etched)
VITALITEC INTERNATIONAL, INC.
PO428-E
In Commercial Distribution

  • 00857987006644 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
PBC228-E (Medium Clip Applier,28cm E Etched)
VITALITEC INTERNATIONAL, INC.
PBC228-E
In Commercial Distribution

  • 00857987006927 ()

  • Length: 28 Centimeter


  • Open-surgery ligation clip applier
SPECIAL 6.5 X 10.5, ORANGE, 2 E
HU-FRIEDY MFG. CO., LLC
IM8123E2
In Commercial Distribution

  • 10889950060688 ()
IM8123E2

  • Device sterilization/disinfection container, reusable
SPECIAL 6.5 X 10.5, GRAY, 2 E
HU-FRIEDY MFG. CO., LLC
IM8121E2
In Commercial Distribution

  • 10889950060411 ()
IM8121E2

  • Device sterilization/disinfection container, reusable
SPECIAL 6.5 X 10.5, RED, 2 E
HU-FRIEDY MFG. CO., LLC
IM8120E2
In Commercial Distribution

  • 10889950060237 ()
IM8120E2

  • Device sterilization/disinfection container, reusable
8 Inst. Sig Cass Gray LP, E
HU-FRIEDY MFG. CO., LLC
IM5081LPE
Not in Commercial Distribution

  • 10889950055790 ()
IM5081LPE

  • Device sterilization/disinfection container, reusable
COVERALL, E/W&A, COLLAR;WHITE, XXXL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080067 ()
  • 00683534080061 ()
68-601W-Z

  • Patient gown, single-use
COVERALL, E/W&A, COLLAR;WHITE, XL
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080043 ()
  • 00683534080047 ()
68-601W-X

  • Patient gown, single-use
COVERALL, E/W&A, COLLAR;WHITE, M
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 80683534080029 ()
  • 00683534080023 ()
68-601W-M

  • Patient gown, single-use
COVERALL, E/W&A, COLLAR;WHITE, L
A PLUS INTERNATIONAL INC.
1
Not in Commercial Distribution

  • 70683534080015 ()
  • 00683534080016 ()
68-601W-L

  • Patient gown, single-use
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