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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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QIAstat-Dx® Respiratory Panel - 04053228033905

No Description
QIAGEN GmbH
V1
Not in Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

NA - 00841379158325

LAMINA HOOK, MEDIUM, NARROW
HYHTE HOLDINGS, INC.
AFAA0NMS0
In Commercial Distribution

  • 00841379158325 ()

  • NARROW
  • MEDIUM
AFAA0NMS0

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369137

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369137 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

Group B Streptococcus Detection Kit(Immunochromatography) - 06974849369120

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
5 tests/kit
In Commercial Distribution

  • 06974849369120 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

GeneXpert® - 07332940008604

Xpert Xpress CoV-2/Flu/RSV plus
CEPHEID
XPRS4PLEX-10
In Commercial Distribution

  • 07332940008604 ()
XPRS4PLEX-10

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Idylla™ Respiratory (IFV-RSV) Panel - 15415219000635

No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Influenza Virus A IgG ELISA - 00404847437935

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)

Influenza Virus A IgG ELISA - 00840239037930

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)

Light Diagnostics™ Influenza A and B DFA Kit - 08436037124594

Influenza A and B DFA Kit
EMD Millipore Corporation
3123
Not in Commercial Distribution

  • 08436037124594 ()
3123

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

HemosIL Routine Control Level 3 - 08426950573401

HemosIL Routine Control Level 3
INSTRUMENTATION LABORATORY COMPANY
00020005800
In Commercial Distribution

  • 08426950573401 ()
  • 18426950573408 ()
00020005800

  • Multiple coagulation factor IVD, control
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