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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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BIOCARE MEDICAL LLC
AVI010G
In Commercial Distribution

  • 00847627024190 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA2447
Not in Commercial Distribution

  • 05055273203820 ()
IA2447

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP2757
In Commercial Distribution

  • 05055273209198 ()
LP2757

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Immunoturbidimetric assay for the quantitative in vitro determination of Lipoprotein(a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP3403
In Commercial Distribution

  • 05055273204421 ()
LP3403

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
For the quantitative in vitro determination of Lipoprotein (a) in human serum or plasma.
RANDOX LABORATORIES LIMITED
LP2878
Not in Commercial Distribution

  • 05055273204384 ()
LP2878

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA7157
In Commercial Distribution

  • 05055273203905 ()
IA7157

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA3895
Not in Commercial Distribution

  • 05055273203899 ()
IA3895

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
RANDOX LABORATORIES LIMITED
IA3832
In Commercial Distribution

  • 05055273203882 ()
IA3832

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
anti-IgA Rabbit Monoclonal Antibody [EP170], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8381-C010
In Commercial Distribution

  • 00615233001931 ()
8381-C010

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
anti-IgA Rabbit Monoclonal Antibody [EP170], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8381-M250
In Commercial Distribution

  • 00615233001924 ()
8381-M250

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
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