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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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Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL
PRIMUS CORPORATION
Premier Buffer A Reagent - 940mL
In Commercial Distribution

  • 05391516744768 ()

  • Total Volume: 940 Milliliter
01-03-0095

  • Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, Enzyme Cleaner Tube
PRIMUS CORPORATION
Enzyme Cleaner Tube
In Commercial Distribution

  • 05391516744546 ()
01-12-0001

  • Medical device-decontamination agent
Hemoglobin A1c assay, 2 Diluent Reagent - 940mL
PRIMUS CORPORATION
2 Diluent Reagent - 940mL
In Commercial Distribution

  • 05391516744317 ()

  • Total Volume: 940 Milliliter
01-03-0059

  • Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L
PRIMUS CORPORATION
2 Diluent Reagent - 3.8L
In Commercial Distribution

  • 05391516744294 ()

  • Total Volume: 3.8 Liter
01-03-0058

  • Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L
PRIMUS CORPORATION
Ultra2 Buffer 2A Reagent - 3.8L
In Commercial Distribution

  • 05391516744287 ()

  • Total Volume: 3.8 Liter
01-03-0054

  • Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL
PRIMUS CORPORATION
Ultra2 Buffer 2A Reagent - 940mL
In Commercial Distribution

  • 05391516744270 ()

  • Total Volume: 940 Milliliter
01-03-0053

  • Glycated haemoglobin (HbA1c) IVD, reagent
Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL
PRIMUS CORPORATION
Mobile Phase 2 Reagent - 940mL
In Commercial Distribution

  • 05391516744263 ()

  • Total Volume: 940 Milliliter
01-03-0044

  • Multiple haemoglobin subtype IVD, reagent
Hemoglobin variants assay, Mobile Phase 1 Reagent - 940mL
PRIMUS CORPORATION
Mobile Phase 1 Reagent - 940mL
In Commercial Distribution

  • 05391516744256 ()

  • Total Volume: 940 Milliliter
01-03-0042

  • Multiple haemoglobin subtype IVD, reagent
Hemoglobin variants assay, Mobile Phase 2 Reagent - 3.8L
PRIMUS CORPORATION
Mobile Phase 2 Reagent - 3.8L
In Commercial Distribution

  • 05391516744249 ()

  • Total Volume: 3.8 Liter
01-03-0041

  • Multiple haemoglobin subtype IVD, reagent
Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L
PRIMUS CORPORATION
Mobile Phase 1 Reagent - 3.8L
In Commercial Distribution

  • 05391516744232 ()

  • Total Volume: 3.8 Liter
01-03-0040

  • Multiple haemoglobin subtype IVD, reagent
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