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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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Trinity Biotech - 05391516748629

Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL
PRIMUS CORPORATION
PDQ Diluent Reagent - 940mL
In Commercial Distribution

  • 05391516748629 ()

  • Total Volume: 940 Milliliter
01-03-0066

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516748612

Hemoglobin A1c assay, PDQ 2 Reagent - 940mL
PRIMUS CORPORATION
PDQ 2 Reagent - 940mL
In Commercial Distribution

  • 05391516748612 ()

  • Total Volume: 940 Milliliter
01-03-0065

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516748605

Hemoglobin A1c assay, PDQ1 Reagent - 940mL
PRIMUS CORPORATION
PDQ1 Reagent - 940mL
In Commercial Distribution

  • 05391516748605 ()

  • Total Volume: 940 Milliliter
01-03-0064

  • Glycated haemoglobin (HbA1c) IVD, reagent

Trinity Biotech - 05391516748193

Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L
PRIMUS CORPORATION
Genesys Diluent Reagent - 3.8L
In Commercial Distribution

  • 05391516748193 ()

  • Total Volume: 3.8 Liter
01-03-0019

  • Multiple haemoglobin subtype IVD, reagent

Trinity Biotech - 05391516748186

Hemoglobin variants assay, Ultra2 Resolution 500 kit
PRIMUS CORPORATION
Ultra2 Resolution 500
In Commercial Distribution

  • 05391516748186 ()
01-04-0078

  • Inherited haemoglobinopathy IVD, reagent

Trinity Biotech - 05391516748162

Hemoglobin A1c assay, Ultra2 Affinity A1c 3000
PRIMUS CORPORATION
Ultra2 Affinity A1c 3000
In Commercial Distribution

  • 05391516748162 ()
01-04-0080

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Trinity Biotech - 05391516748148

Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit
PRIMUS CORPORATION
Premier Affinity A1c 3000 - 1 kit
In Commercial Distribution

  • 05391516748148 ()
09-03-0007

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Trinity Biotech - 05391516748131

Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit
PRIMUS CORPORATION
Premier Affinity A1c 1000 - 1 kit
In Commercial Distribution

  • 05391516748131 ()
09-03-0010

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Trinity Biotech - 05391516748124

Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit
PRIMUS CORPORATION
Premier Affinity A1c 500 - 1 kit
In Commercial Distribution

  • 05391516748124 ()
09-03-0008

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Trinity Biotech - 05391516748117

Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL
PRIMUS CORPORATION
Premier Sample Diluent Reagent - 940mL
In Commercial Distribution

  • 05391516748117 ()

  • Total Volume: 940 Milliliter
01-03-0101

  • Glycated haemoglobin (HbA1c) IVD, reagent
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