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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VITROS Immunodiagnostic Products HAV Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution

  • 10758750001477 ()
  • 20758750001474 ()
6801823

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801812
In Commercial Distribution

  • 10758750001415 ()
  • 20758750001412 ()
6801812

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801462
In Commercial Distribution

  • 10758750001286 ()
  • 20758750001283 ()
6801462

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
3M™ Attest™ VH2O2 Tri-Metric Chemical Indicator, 250 each/pouch, 4 pouches/case, 1348E
3M COMPANY
1348E
In Commercial Distribution

  • 50707387788013 ()
  • 30707387788019 ()
  • 00707387788018 ()
1348E

  • Chemical/physical sterilization process indicator
3M™ Attest™ VH2O2 Tri-Metric Chemical Indicator, 250 each/pouch, 4 pouches/case, 1348
3M COMPANY
1348
In Commercial Distribution

  • 00707387788001 ()
  • 30707387788002 ()
  • 50707387788006 ()
1348

  • Chemical/physical sterilization process indicator
Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated
Hemodialysis Pack
ARGON MEDICAL DEVICES, INC.
500326D
Not in Commercial Distribution

  • 20886333215847 ()
  • 00886333215843 ()
500326D

  • General surgical procedure kit, medicated
Acute Hemodialysis Tray
ARGON MEDICAL DEVICES, INC.
500320F
Not in Commercial Distribution

  • 20886333215830 ()
  • 00886333215836 ()
500320F

  • General surgical procedure kit, medicated
D3 Duet DFA Influenza A/Respiratory Virus Screening kit
DIAGNOSTIC HYBRIDS, INC.
01-200000
In Commercial Distribution

  • 30014613330882 ()
01-200000

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
FASTPOINT FLUA/B KIT BX 2
DIAGNOSTIC HYBRIDS, INC.
01-120001.B2
In Commercial Distribution

  • 30014613330806 ()
01-120001.B2

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT BX 1
DIAGNOSTIC HYBRIDS, INC.
01-120001.B1
In Commercial Distribution

  • 30014613330790 ()
01-120001.B1

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT
DIAGNOSTIC HYBRIDS, INC.
01-120001
In Commercial Distribution

  • 30014613330783 ()
01-120001

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Parainfluenza 3 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013702.V2
In Commercial Distribution

  • 30014613330479 ()
01-013702.V2

  • Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay
Parainfluenza 2 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013602.V2
In Commercial Distribution

  • 30014613330462 ()
01-013602.V2

  • Human parainfluenza virus 2 antigen IVD, kit, fluorescent immunoassay
Parainfluenza 1 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013502.V2
In Commercial Distribution

  • 30014613330455 ()
01-013502.V2

  • Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay
D3 DFA 500 ML SCR REAGENT
DIAGNOSTIC HYBRIDS, INC.
01-013500.V2-BULK
In Commercial Distribution

  • 30014613330448 ()
01-013500.V2-BULK

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Adeno DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013402.V2
In Commercial Distribution

  • 30014613330431 ()
01-013402.V2

  • Adenovirus antigen IVD, kit, fluorescent immunoassay
RSV DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013302.V2
In Commercial Distribution

  • 30014613330424 ()
01-013302.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
Influenza B DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013200.V2-BULK
In Commercial Distribution

  • 30014613330400 ()
01-013200.V2-BULK

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
Influenza A DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013102.V2
In Commercial Distribution

  • 30014613330394 ()
01-013102.V2

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay
Influenza A DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013100.V2-BULK
In Commercial Distribution

  • 30014613330387 ()
01-013100.V2-BULK

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay
DFA Respiratory Virus Screening Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013010.V2
In Commercial Distribution

  • 30014613330370 ()
01-013010.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
DFA Respiratory Virus Screening Reagent - Bulk
DIAGNOSTIC HYBRIDS, INC.
01-013000.V2-BULK
In Commercial Distribution

  • 30014613330363 ()
01-013000.V2-BULK

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
BIOCARE MEDICAL LLC
NPAI010T40
In Commercial Distribution

  • 00847627037718 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
OPAI010T60
In Commercial Distribution

  • 00847627025173 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
PM010AA
In Commercial Distribution

  • 00847627010636 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
IP010G10
In Commercial Distribution

  • 00847627008459 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM171A
In Commercial Distribution

  • 00847627006707 ()


  • Inhibin A IVD, kit, enzyme immunohistochemistry
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