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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Axilum Robotics TMS-Cobot TS MV
AXILUM ROBOTICS
TMS-Cobot-2
In Commercial Distribution

  • 03701354620117 ()
2-01-01

  • Magnetic neural stimulation system
Axilum Robotics TMS-Cobot TS MV
AXILUM ROBOTICS
TMS-Cobot-2
Not in Commercial Distribution

  • 03701354600058 ()
2-01-02

  • Magnetic neural stimulation system
Coil adaptation kit for MagVenture Cool-B65-CO coil, for TMS-Cobot TS MV
AXILUM ROBOTICS
ADAP-MAGV-CB65A-12
Not in Commercial Distribution

  • 03701354600034 ()
2-02-18

  • Magnetic neural stimulation system
Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422852
In Commercial Distribution

  • 05019279403844 ()

  • A
32-422852

  • Surgical implant template, reusable
Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422851
In Commercial Distribution

  • 05019279403837 ()

  • A
32-422851

  • Surgical implant template, reusable
Tubigrip A Natural x 10m
Mölnlycke Health Care AB
1435
In Commercial Distribution

  • 07332551947873 ()
  • 07332551449384 ()
  • 07332551449391 ()

  • A


  • Tubular support bandage, Hevea-latex
Polyclonal Rabbit Anti-Human IgA/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0204
In Commercial Distribution

  • 05700572002543 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0262
In Commercial Distribution

  • 05700572001140 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA, IgG, IgM
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0190
In Commercial Distribution

  • 05700572000860 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0092
In Commercial Distribution

  • 05700572000617 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
NCL-L-IgA is intended for the qualitative identification by light microscopy of human immunoglobulin A (IgA) molecules in paraffin sections
LEICA BIOSYSTEMS NEWCASTLE LTD
IGA-L-CE
In Commercial Distribution

  • 05055331308023 ()
NCL-L-IgA

  • Total immunoglobulin A (IgA total) IVD, antibody
NCL-L-IgA-U is intended for the qualitative identification by light microscopy of human immunoglobulin A (IgA) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
IGA-L-U
In Commercial Distribution

  • 05055331333841 ()
NCL-L-IGA-U

  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA/FITC Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0188
In Commercial Distribution

  • 05700572031949 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
FLEX Polyclonal Rabbit Anti-Human IgA Ready-to-Use (Link)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IR510
In Commercial Distribution

  • 05700572029465 ()

  • 40-60 Tests


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA/FITC Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0316
In Commercial Distribution

  • 05700572029120 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA/HRP
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
P0216
In Commercial Distribution

  • 05700572007388 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
No Description
THE BINDING SITE GROUP LIMITED
MA010
In Commercial Distribution

  • 05051700020329 ()


  • Total immunoglobulin A (IgA total) IVD, reagent
No Description
THE BINDING SITE GROUP LIMITED
NQ624.OPT
In Commercial Distribution

  • 05051700019439 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ623.OPT
In Commercial Distribution

  • 05051700019422 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ087.OPT
In Commercial Distribution

  • 05051700019330 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ088.OPT
In Commercial Distribution

  • 05051700019262 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ010.OPT
In Commercial Distribution

  • 05051700019101 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ010.S
Not in Commercial Distribution

  • 05051700018890 ()


  • Total immunoglobulin A (IgA total) IVD, control
The Follistatin enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of follistatin in human serum and other biological fluids. This kit is intended for in-vitro diagnostic use.
Ansh Labs, LLC
AL-117-i
In Commercial Distribution

  • 00853592008387 ()
AL-117-i

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Ansh Labs, LLC
AL-123
In Commercial Distribution

  • 00853592008097 ()
AL-123

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Down syndrome (Trisomy 21) screening in the 2nd trimester using combined biochemical and ultrasound markers may be assessed with appropriate risk calculation software.1,2 It is strongly recommended to use validated software (CE marked) designated specifically for evaluating the risk of Trisomy 21 using Inhibin A in combination with hAFP, hCG, and uE3 measurements.
Ansh Labs, LLC
AL-123-i
In Commercial Distribution

  • 00853592008073 ()
AL-123-i

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Activin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Activin A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use.
Ansh Labs, LLC
AL-110-i
In Commercial Distribution

  • 00853592008059 ()
AL-110-i

  • Activin A IVD, kit, enzyme immunoassay (EIA)
No Description
CELL MARQUE CORPORATION
267R-18
In Commercial Distribution

  • 00841683131885 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267R-17
In Commercial Distribution

  • 00841683131878 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267R-16
In Commercial Distribution

  • 00841683131861 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267R-15
In Commercial Distribution

  • 00841683131854 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267R-14
In Commercial Distribution

  • 00841683131847 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267A-18
In Commercial Distribution

  • 00841683131830 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267A-17
In Commercial Distribution

  • 00841683131823 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267A-16
In Commercial Distribution

  • 00841683131816 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267A-15
In Commercial Distribution

  • 00841683131809 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
267A-14
In Commercial Distribution

  • 00841683131793 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
No Description
CELL MARQUE CORPORATION
251R-18
In Commercial Distribution

  • 00841683130598 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251R-17
In Commercial Distribution

  • 00841683130581 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251R-16
In Commercial Distribution

  • 00841683130574 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251R-15
In Commercial Distribution

  • 00841683130567 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251R-14
In Commercial Distribution

  • 00841683130550 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251M-18
In Commercial Distribution

  • 00841683130543 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251M-17
In Commercial Distribution

  • 00841683130536 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251M-16
In Commercial Distribution

  • 00841683130529 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251M-15
In Commercial Distribution

  • 00841683130512 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
251M-14
In Commercial Distribution

  • 00841683130505 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4441
In Commercial Distribution

  • 00841683100980 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4384
In Commercial Distribution

  • 00841683100805 ()


  • Coagulation factor XIII A subunit IVD, antibody
No Description
CELL MARQUE CORPORATION
760-2652
In Commercial Distribution

  • 00841683100188 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, antibody
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