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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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SpineSmith Fusionary Graft Delivery System - 00817771027323

BMA Kit Standard
Celling Biosciences
0851-0061
In Commercial Distribution

  • 00817771027323 ()
0851-0061

  • Bone graft syringe, single-use

DG Gel Extended Control - 07640137340605

DG Gel Extended Control is intended to allow regular quality control of materials, work procedures and instrument procedures. For use with DG Gel 8 technique. For in vitro diagnostic use.
Medion Grifols Diagnostics AG
4 x 6 ml
In Commercial Distribution

  • 07640137340605 ()
213285

  • Multiple immunohaematology test IVD, control

Epicel (cultured epidermal autografts) - W41020AU201S1969

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

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® - 00816784020871

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® - 00816784020802

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® - 00816784020789

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® - 00816784020772

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® - 00816784020765

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® - 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

ACCURUN® - 00816784020604

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® - 00816784020598

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® - 00816784020581

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® - 00816784020574

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® - 00816784020567

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® - 00816784020550

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® - 00816784020536

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® - 00816784020529

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® - 00816784020512

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® - 00816784020505

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® - 00816784020475

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® - 00816784020468

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® - 00816784020451

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® - 00816784020437

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® - 00816784020260

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® - 00816784020253

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® - 00816784020222

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® - 00816784020215

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® - 00816784020123

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® - 00816784020062

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® - 00816784020055

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® - 00816784020048

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® - 00816784020031

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® - 00816784020024

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

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

Celling ART PRP System - 00817771027569

ART PRP Plus Processing Kit
Celling Biosciences
0885-2000
In Commercial Distribution

  • 00817771027569 ()
0885-2000

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027545

ART PRP Processing Kit
Celling Biosciences
0885-1000
In Commercial Distribution

  • 00817771027545 ()
0885-1000

  • Haematological concentrate system preparation kit, platelet concentration

Celling ART PRP System - 00817771027491

ART PRP Device
Celling Biosciences
0885-0001
In Commercial Distribution

  • 00817771027491 ()
0885-0001

  • Haematological concentrate system preparation kit, platelet concentration
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