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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A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.
GERMAINE LABORATORIES, INC
77025
In Commercial Distribution

  • 00695684770259 ()
  • 00695684770251 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128B
In Commercial Distribution

  • 00847661005575 ()
00128B

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128A
In Commercial Distribution

  • 00847661005568 ()
00128A

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROCLEAR EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00131
In Commercial Distribution

  • 00847661002727 ()
00131

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
TRANSVERSE CONNECTOR, SIZE M
SPINEWAY
2
In Commercial Distribution

  • 03663422002068 ()

  • Taille : M
MB2DTTM

  • Bone-screw internal spinal fixation system, sterile
ENF-TL M/M Transitional Connector
Medela LLC
ENFMALE
Not in Commercial Distribution

  • 20020451100351 ()
  • 00020451100357 ()


  • Enteral feeding/medication connector, sterile
No Description
I M T
3.2.1
In Commercial Distribution

  • 03760264690115 ()


  • Cardiovascular risk evaluation interpretive software
No Description
I M T
3.2.1 SR
In Commercial Distribution

  • 03760264690061 ()


  • Cardiovascular risk evaluation interpretive software
No Description
M DIALYSIS INC.
English
In Commercial Distribution

  • 07332699000751 ()
8001027

  • Bedside information system
No Description
Bion Enterprises, Ltd.
EBN-5010
In Commercial Distribution

  • B110EBN50100 ()
EBN-5010

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
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