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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-4 G
In Commercial Distribution

  • 04049016061472 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-3 G
In Commercial Distribution

  • 04049016061335 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-3 G
In Commercial Distribution

  • 04049016061311 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-2 G
In Commercial Distribution

  • 04049016061175 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-2 G
In Commercial Distribution

  • 04049016061151 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-1 G
In Commercial Distribution

  • 04049016060994 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 M
Not in Commercial Distribution

  • 04049016028352 ()


  • Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution

  • 04049016028345 ()


  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 A
Not in Commercial Distribution

  • 04049016028338 ()


  • Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 G
Not in Commercial Distribution

  • 04049016028321 ()


  • Influenza A/B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 M
Not in Commercial Distribution

  • 04049016028307 ()


  • Influenza A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 G
In Commercial Distribution

  • 04049016028291 ()


  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

  • 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).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
Not in Commercial Distribution

  • 00404847437935 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
In Commercial Distribution

  • 04048474037968 ()
EIA-3796

  • 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).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
In Commercial Distribution

  • 04048474037937 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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).
DRG International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • 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).
DRG International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07026757190
In Commercial Distribution

  • 04015630939916 ()
07026757190

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026773190
In Commercial Distribution

  • 04015630939855 ()
07026773190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820591160
In Commercial Distribution

  • 04015630938858 ()
11820591160

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
5524261160
In Commercial Distribution

  • 04015630938841 ()
5524261160

  • Hepatitis A virus antigen 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
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated
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