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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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IntraSpin Fuse, IS110
INTRA-LOCK INTERNATIONAL, INC.
BFUSE110
In Commercial Distribution

  • D742BFUSE1101 ()
BFUSE110

  • Haematological concentrate system
No Description
BIOACCESS INC
MH2150
In Commercial Distribution

  • M791MH21500 ()


  • Bone marrow collection/transfusion set
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
Home Access Health Corporation
21
In Commercial Distribution

  • M769HIVSTANDARD211 ()


  • Capillary blood collection set, home-use
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
L-PRF White Cap Plain Z Tube (9 ml)
INTRA-LOCK INTERNATIONAL, INC.
WCT_50
In Commercial Distribution

  • D742WCT50 ()
WCT_50

  • Blood collection set, noninvasive
Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
PLT Control
In Commercial Distribution

  • 15099590639402 ()
175651

  • Full blood count IVD, control
Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control
stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD
StemTrol Control Cells
Beckman Coulter, Inc.
IM3632
In Commercial Distribution

  • 15099590220020 ()
IM3632

  • Fixative, Orth's solution
StemComp Reagent
Beckman Coulter, Inc.
IM3631
In Commercial Distribution

  • 15099590220013 ()
IM3631

  • Fixative, Orth's solution
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