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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HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Version with LAN and integrated RFID options installed)
DELCON SRL
HMIX3.LAN.RFID
In Commercial Distribution

  • 08033928530047 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Version with LAN option installed)
DELCON SRL
HMIX3.LAN
In Commercial Distribution

  • 08033928530030 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Version with internal RFID option installed)
DELCON SRL
HMIX3.485.RFID
In Commercial Distribution

  • 08033928530023 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached (Basic version))
DELCON SRL
HMIX3.485
In Commercial Distribution

  • 08033928530016 ()


  • Blood donation rocker
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells.
Bio-Rad Medical Diagnostics GmbH
12008722
In Commercial Distribution

  • 03610522055685 ()
12008722

  • Column agglutination IVD
IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution

  • 03610520569870 ()
009100

  • Laboratory instrument/analyser application software IVD
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 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 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0005
In Commercial Distribution

  • 00816784020871 ()
2000-0005

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0093
In Commercial Distribution

  • 00816784020802 ()
2020-0093

  • HIV1 nucleic acid IVD, control
ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0022
In Commercial Distribution

  • 00816784020789 ()
2000-0022

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0017
In Commercial Distribution

  • 00816784020772 ()

  • Total Volume: 42 Milliliter
2000-0017

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

  • Multiple blood-borne virus antigen/antibody IVD, control
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 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
ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 315 Series 400 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0092
In Commercial Distribution

  • 00816784020574 ()
2020-0092

  • HIV1 nucleic acid IVD, control
ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0090
In Commercial Distribution

  • 00816784020567 ()
2020-0090

  • HIV1 nucleic acid IVD, control
ACCURUN 315 Series 150 HIV-1 RNA 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2020-0087
In Commercial Distribution

  • 00816784020550 ()
2020-0087

  • HIV1 nucleic acid IVD, control
ACCURUN 305 Series 400 HCV RNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0085
In Commercial Distribution

  • 00816784020536 ()
2020-0085

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 300 HCV RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0083
In Commercial Distribution

  • 00816784020529 ()
2020-0083

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0080
In Commercial Distribution

  • 00816784020512 ()
2020-0080

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2020-0078
In Commercial Distribution

  • 00816784020505 ()
2020-0078

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0093
In Commercial Distribution

  • 00816784020475 ()

  • Total Volume: 6 Milliliter
2015-0093

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0092
In Commercial Distribution

  • 00816784020468 ()

  • Total Volume: 42 Milliliter
2015-0092

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0090
In Commercial Distribution

  • 00816784020451 ()
2015-0090

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 145 CMV IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0087
In Commercial Distribution

  • 00816784020437 ()
2015-0087

  • Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0066
In Commercial Distribution

  • 00816784020260 ()
2015-0066

  • HIV1 antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0065
In Commercial Distribution

  • 00816784020253 ()
2015-0065

  • HIV1 antigen IVD, control
ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2010-0015
In Commercial Distribution

  • 00816784020222 ()

  • Total Volume: 42 Milliliter
2010-0015

  • Negative control immunoglobulin IVD
ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2010-0013
In Commercial Distribution

  • 00816784020215 ()

  • Total Volume: 5 Milliliter
2010-0013

  • Negative control immunoglobulin IVD
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution

  • 00816784020123 ()
2000-0032

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution

  • 00816784020062 ()
2000-0018

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution

  • 00816784020055 ()
2000-0010

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution

  • 00816784020048 ()
2000-0008

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution

  • B73810071 ()


  • Haematological concentrate system
No Description
Luvo Medical Technologies Inc
WORLDPRP
In Commercial Distribution

  • 00754016214127 ()
  • 10754016214124 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set
Aurix Ten Pack Kit Case of 10 Wound Dressing Kits and 10 Reagent Kits with 010513 Aurix Ten Pack Kit Label
Nuo Therapeutics, Inc.
AGWR-04
In Commercial Distribution

  • 10852714003153 ()


  • Wound dressing kit, medicated
Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-08
In Commercial Distribution

  • 10852714003146 ()


  • Wound dressing kit, medicated
Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-05
In Commercial Distribution

  • 10852714003139 ()


  • Wound dressing kit, medicated
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