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

  • 10859394006061 ()
  • 00859394006064 ()
30-201

  • Multiple coagulation factor IVD, control
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
PT reagent 10 x 10 ml
R 2 DIAGNOSTICS, INC.
11-310
In Commercial Distribution

  • 10859394006030 ()
  • 00859394006033 ()
11-310

  • Prothrombin time (PT) IVD, reagent
PT reagent 10 x 5 ml
R 2 DIAGNOSTICS, INC.
11-305
In Commercial Distribution

  • 10859394006023 ()
  • 00859394006026 ()
11-305

  • Prothrombin time (PT) IVD, reagent
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
Protein S Kit 80-160 DET
R 2 DIAGNOSTICS, INC.
90-480
In Commercial Distribution

  • 00859394006095 ()
90-480

  • Protein S IVD, kit, clotting
Fibrinogen assay 100 DET
R 2 DIAGNOSTICS, INC.
70-410
In Commercial Distribution

  • 00859394006040 ()
70-410

  • Fibrinogen assay (factor I) IVD, kit, clotting
The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
RINOVUM SUBSIDIARY 2, LLC
0025
In Commercial Distribution

  • 20854389008027 ()
  • 10854389008020 ()
  • 00854389008023 ()
  • 00854389008009 ()
0025

  • Urinary-incontinence vaginal insert, reusable
Polymer Patient Exam Gloves Large
Cintas Corporation No. 2
182309
In Commercial Distribution

  • 10850047958997 ()
  • 00850047958990 ()


  • Surgical/examination garment kit
Forehead Thermometers
Cintas Corporation No. 2
619369
In Commercial Distribution

  • 10850053907170 ()
  • 00850053907173 ()


  • Colour-indication patient thermometer
Naloxone Opioid Overdose Kit
Cintas Corporation No. 2
620859
In Commercial Distribution

  • 00850053907142 ()


  • First aid kit, medicated
Rabbit Monoclonal Anti-Human TACSTD2, concentrated
Epitomics Inc.
AC-0378BULK
In Commercial Distribution

  • 00810138720431 ()


  • Trophoblast antigen 2 (TROP2) IVD, antibody
Rabbit Monoclonal Anti-Human TACSTD2, 0.5 mL concentrated
Epitomics Inc.
AC-0378B
In Commercial Distribution

  • 00810138720424 ()

  • Total Volume: 0.5 Milliliter


  • Trophoblast antigen 2 (TROP2) IVD, antibody
Rabbit Monoclonal Anti-Human TACSTD2, 0.1 mL concentrated
Epitomics Inc.
AC-0378A
In Commercial Distribution

  • 00810138720417 ()

  • Total Volume: 0.1 Milliliter


  • Trophoblast antigen 2 (TROP2) IVD, antibody
Rabbit Monoclonal Anti-Human TACSTD2, 1mL concentrated
Epitomics Inc.
AC-0378
In Commercial Distribution

  • 00810138720400 ()


  • Trophoblast antigen 2 (TROP2) IVD, antibody
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