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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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PlasmaRef ARL-2 - 10859394006184

Assayed Reference Plasma L-2 10 x 1 ml
R 2 DIAGNOSTICS, INC.
35-201
In Commercial Distribution

  • 10859394006184 ()
  • 00859394006187 ()
35-201

  • Plasma protein IVD, calibrator

PlasmaRef ARN - 10859394006177

Assayed Reference Plasma 10 x 1 ml
R 2 DIAGNOSTICS, INC.
33-201
In Commercial Distribution

  • 10859394006177 ()
  • 00859394006170 ()
33-201

  • Plasma protein IVD, calibrator

NoFact IX - 10859394006160

Factor IX immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
69-201
In Commercial Distribution

  • 10859394006160 ()
  • 00859394006163 ()
69-201

  • Coagulation factor IX IVD, kit, clotting

NoFact VIII - 10859394006153

Factor VIII immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
68-201
In Commercial Distribution

  • 10859394006153 ()
  • 00859394006156 ()
68-201

  • Coagulation factor VIII IVD, kit, clotting

LupoTek KCT - 10859394006146

Screening test for LA 250 DET
R 2 DIAGNOSTICS, INC.
87-305
In Commercial Distribution

  • 10859394006146 ()
  • 00859394006149 ()
87-305

  • Lupus anticoagulant marker IVD, kit, clotting

PlasmaCon LA - 10859394006139

Positive control for LA 10 x 1 ml
R 2 DIAGNOSTICS, INC.
150-201
In Commercial Distribution

  • 10859394006139 ()
  • 00859394006132 ()
150-201

  • Multiple coagulation factor IVD, control

PlasmaCon LA - 10859394006122

Positive control for LA 10 x 0.5 ml
R 2 DIAGNOSTICS, INC.
150-200
In Commercial Distribution

  • 10859394006122 ()
  • 00859394006125 ()
150-200

  • Multiple coagulation factor IVD, control

LupoTek Correctin VL - 10859394006115

Venom Confirmatory test for LA 10 x 1 ml
R 2 DIAGNOSTICS, INC.
86-201
In Commercial Distribution

  • 10859394006115 ()
  • 00859394006118 ()
86-201

  • Lupus anticoagulant marker IVD, kit, clotting

LupoTek Detectin VL - 10859394006108

Venom Screening test of LA 10 x 2 ml
R 2 DIAGNOSTICS, INC.
85-202
In Commercial Distribution

  • 10859394006108 ()
  • 00859394006101 ()
85-202

  • Lupus anticoagulant marker IVD, kit, clotting

PlasmaCon L2 - 10859394006085

Abnormal Control L-2 10 x 1 ml
R 2 DIAGNOSTICS, INC.
32-201
In Commercial Distribution

  • 10859394006085 ()
  • 00859394006088 ()
32-201

  • Multiple coagulation factor IVD, control
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