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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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Precise - M896AMS500350530

Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-053
In Commercial Distribution

  • M896AMS500350530 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500350500

Precise Separation Canister, 120 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50035-050
In Commercial Distribution

  • M896AMS500350500 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500220560

Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-056
In Commercial Distribution

  • M896AMS500220560 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500220530

Precise Separation Canister, 60mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-053
In Commercial Distribution

  • M896AMS500220530 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise - M896AMS500220500

Precise Separation Canister, 60 mL
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AMS50022-050
In Commercial Distribution

  • M896AMS500220500 ()


  • Haematological concentrate system preparation kit, platelet concentration

ABORhCard - 00815312020000

Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
MICRONICS, INC.
BT-101-025
In Commercial Distribution

  • 00815312020000 ()
  • 00815312020048 ()
BT-101-025

  • ABO/Rh multiple blood grouping IVD, kit, agglutination

ACCURUN® 365 Series 200 - 00816784020901

ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.
Lgc Clinical Diagnostics, Inc.
2020-0107
In Commercial Distribution

  • 00816784020901 ()
2020-0107

  • West Nile virus nucleic acid IVD, control

ACCURUN® - 00816784020888

ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Lgc Clinical Diagnostics, Inc.
2000-0006
In Commercial Distribution

  • 00816784020888 ()
2000-0006

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020628

ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution

  • 00816784020628 ()

  • Total Volume: 20 Milliliter
2020-0105

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

ACCURUN® - 00816784020611

ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution

  • 00816784020611 ()

  • Total Volume: 5 Milliliter
2020-0104

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
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