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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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PRO ADVANTAGE A 25/BX
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080033
In Commercial Distribution

  • M220P0800335 ()
  • M220P0800333 ()
P080033

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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
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
EliA IgA Calibrator Well
Phadia AB
DECC055160
In Commercial Distribution

  • 07333066010694 ()
  • 07333066014654 ()
DECC055160

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
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)
EliA IgA Conjugate 200
Phadia AB
83-0003-61
In Commercial Distribution

  • 07333066013794 ()
  • 07333066012865 ()
83-0003-61

  • Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)
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