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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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HLA-DR [TAL 1B5] - 00847627028600

No Description
BIOCARE MEDICAL LLC
ALI3273G7
In Commercial Distribution

  • 00847627028600 ()


  • HLA-DR antigen tissue typing IVD, antibody

CO2 - 05055273201086

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD7942
Not in Commercial Distribution

  • 05055273201086 ()
CD7942

  • Bicarbonate (HCO3-) IVD, reagent

CO2 - 05055273201031

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD129
In Commercial Distribution

  • 05055273201031 ()
CD129

  • Bicarbonate (HCO3-) IVD, reagent

CO2 - 05055273201024

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD127
In Commercial Distribution

  • 05055273201024 ()
CD127

  • Bicarbonate (HCO3-) IVD, reagent

CO2 - 05055273201017

The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma.
RANDOX LABORATORIES LIMITED
CD116
Not in Commercial Distribution

  • 05055273201017 ()
CD116

  • Bicarbonate (HCO3-) IVD, reagent

ALT - 05055273200218

An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma.
RANDOX LABORATORIES LIMITED
AL3801
In Commercial Distribution

  • 05055273200218 ()
AL3801

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

IMMCO DIAGNOSTICS - 00845714004353

Serum Diluent
IMMCO DIAGNOSTICS, INC.
2308
In Commercial Distribution

  • 00845714004353 ()

  • 60 ml
2308

  • Buffered sample diluent IVD, manual

IMMCO DIAGNOSTICS - 00845714004308

Phosphate Buffered Saline
IMMCO DIAGNOSTICS, INC.
2301
In Commercial Distribution

  • 00845714004308 ()

  • 1 L
2301

  • Buffered sample diluent IVD, manual

IMMCO DIAGNOSTICS - 00845714004247

WASH BUFFER
IMMCO DIAGNOSTICS, INC.
2308-1
In Commercial Distribution

  • 00845714004247 ()

  • for 1 liter
2308-1

  • Buffered wash solution IVD, manual

IMMCO DIAGNOSTIC - 00845714004186

Counterstain
IMMCO DIAGNOSTICS, INC.
2510
In Commercial Distribution

  • 00845714004186 ()

  • 1 ml
2510

  • Evans blue solution IVD
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