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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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10-Strip; Strep A Throat Swab Test
WONDFO USA CO., LTD.
PRE-STA-10
In Commercial Distribution

  • 10816862023722 ()
  • 00816862023725 ()
  • 00816862023732 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
25-Strip; Strep A Throat Swab Test
WONDFO USA CO., LTD.
PRE-STA-25
In Commercial Distribution

  • 10816862023586 ()
  • 00816862023589 ()
  • 00816862023596 ()
PRE-STA-25

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
25-Strip; Strep A Throat Swab Test
WONDFO USA CO., LTD.
W39-S
In Commercial Distribution

  • 10816862021056 ()
  • 00816862021059 ()
  • 00816862028058 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
MONOBIND, INC.
11825-300
In Commercial Distribution

  • 00816870023564 ()

  • Width: 7.75 Inch
11825-300B

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
11825-300
In Commercial Distribution

  • 00816870023557 ()

  • Width: 7.75 Inch
11825-300A

  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
1675-300
In Commercial Distribution

  • 00816870022727 ()

  • Width: 7.75 Inch
1675-300A

  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, chemiluminescent immunoassay
Strep A Rapid Test Strip (Throat Swab)
JANT PHARMACAL CORPORATION
ID513
In Commercial Distribution

  • 10763924513199 ()
  • 00763924513192 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.
Phadia AB
83-1013-01
In Commercial Distribution

  • 07333066020075 ()
83-1013-01

  • 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)
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