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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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EliA IgA Curve Control
Phadia AB
83-0002-71
In Commercial Distribution

  • 07333066013688 ()
  • 07333066012773 ()
83-0002-71

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgA Conjugate
Phadia AB
34-2328-11
In Commercial Distribution

  • 07333066000510 ()
  • 07333066012230 ()
34-2328-11

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgA method.
Phadia AB
10-9308-01
In Commercial Distribution

  • 07333066019574 ()
10-9308-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
Contains one vial of each Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0) to form a complete calibration curve for the ImmunoCAP Specific IgA method.
Phadia AB
10-9304-01
In Commercial Distribution

  • 07333066019550 ()
10-9304-01

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Calibrator Well
Phadia AB
DECC055160
In Commercial Distribution

  • 07333066010694 ()
  • 07333066014654 ()
DECC055160

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5645
In Commercial Distribution

  • 00840239056450 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
BioStrep® A strip; 30 Test kit; CE; for LifeSign (Infolab)
PRINCETON BIOMEDITECH CORPORATION
BSP-185-30-06
In Commercial Distribution

  • 10743816000907 ()
BSP-185-30-06

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
BioStrep® A strip; 30 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-185-30-04
In Commercial Distribution

  • 10743816000891 ()
BSP-185-30-04

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A strip; 12 Test sample kit
PRINCETON BIOMEDITECH CORPORATION
BSP-185-12-00
In Commercial Distribution

  • 10743816000884 ()
BSP-185-12-00

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A strip; 30 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-185-30-01
In Commercial Distribution

  • 10743816000877 ()
BSP-185-30-01

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