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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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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

PlasmaCon L1 - 10859394006078

Abnormal Control L-1 10 x 1 ml
R 2 DIAGNOSTICS, INC.
31-201
In Commercial Distribution

  • 10859394006078 ()
  • 00859394006071 ()
31-201

  • Multiple coagulation factor IVD, control

PlasmaCon N - 10859394006061

Normal Control 10 x 1 ml
R 2 DIAGNOSTICS, INC.
30-201
In Commercial Distribution

  • 10859394006061 ()
  • 00859394006064 ()
30-201

  • Multiple coagulation factor IVD, control

T-tek - 10859394006054

Thrombin Time 10 x 1 ml
R 2 DIAGNOSTICS, INC.
50-201
In Commercial Distribution

  • 10859394006054 ()
  • 00859394006057 ()
50-201

  • Thrombin time (TT) IVD, kit, clotting

Phosphoplastin RL - 10859394006030

PT reagent 10 x 10 ml
R 2 DIAGNOSTICS, INC.
11-310
In Commercial Distribution

  • 10859394006030 ()
  • 00859394006033 ()
11-310

  • Prothrombin time (PT) IVD, reagent

Phosphoplastin RL - 10859394006023

PT reagent 10 x 5 ml
R 2 DIAGNOSTICS, INC.
11-305
In Commercial Distribution

  • 10859394006023 ()
  • 00859394006026 ()
11-305

  • Prothrombin time (PT) IVD, reagent

Phospholin ES w/ Calcium Chloride - 10859394006016

APTT reagent 5 x 10 ml with 5 Calcium Chloride
R 2 DIAGNOSTICS, INC.
21-410
In Commercial Distribution

  • 10859394006016 ()
  • 00859394006019 ()
21-410

  • Activated partial thromboplastin time (APTT) IVD, reagent

ThromboTek PSe - 00859394006095

Protein S Kit 80-160 DET
R 2 DIAGNOSTICS, INC.
90-480
In Commercial Distribution

  • 00859394006095 ()
90-480

  • Protein S IVD, kit, clotting
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