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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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ImmunoCAP Total IgE Calibrators - 07333066019512

Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method.
Phadia AB
10-9252-01
In Commercial Distribution

  • 07333066019512 ()
10-9252-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

ST AIA-PACK IgEII - 14560189210155

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210155 ()
  • 04560189210158 ()


  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

Anti-e (Monoclonal Blend) Gamma-clone - 10888234001379

This reagent is used for the detection of the e antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0066424
In Commercial Distribution

  • 10888234001379 ()
0066424

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Anti-E (Monoclonal) Gamma-clone - 10888234001362

This reagent is intended for the detection of the E antigen on red blood cells. This E antigen is part of the Rhesus blood group system.
IMMUCOR, INC.
0066422
In Commercial Distribution

  • 10888234001362 ()
0066422

  • Anti-E [RH003] red blood cell grouping IVD, antibody

ALBAclone® Anti-e - 05060242471674

This Anti-e reagent is for the in vitro detection and identification of the human e blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z096U
In Commercial Distribution

  • 05060242471674 ()
  • 05060242472565 ()
  • 05060242472572 ()


  • Anti-E [RH005] red blood cell grouping IVD, antibody

ALBAclone Anti-E - 05060242471469

Blood Grouping Reagent, ALBAclone Anti-E (Human/Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z073U
In Commercial Distribution

  • 05060242471469 ()
  • 05060242471315 ()


  • Anti-E [RH003] red blood cell grouping IVD, antibody

IH-Card Anti-e - 07611969964727

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813242100
In Commercial Distribution

  • 07611969964727 ()
813242100

  • Anti-E [RH005] red blood cell grouping IVD, antibody

IH-Card Anti-e - 07611969964710

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813240100
In Commercial Distribution

  • 07611969964710 ()
813240100

  • Anti-E [RH005] red blood cell grouping IVD, antibody

IH-Card Anti-E - 07611969964680

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813222100
In Commercial Distribution

  • 07611969964680 ()
813222100

  • Anti-E [RH003] red blood cell grouping IVD, antibody

IH-Card Anti-E - 07611969964673

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813220100
In Commercial Distribution

  • 07611969964673 ()
813220100

  • Anti-E [RH003] red blood cell grouping IVD, antibody

IH-Card Anti-E - 07611969962372

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813221100
In Commercial Distribution

  • 07611969962372 ()
813221100

  • Anti-E [RH003] red blood cell grouping IVD, antibody

IH-Card Anti-e - 07611969962396

Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 48 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813241100
In Commercial Distribution

  • 07611969962396 ()
813241100

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Seraclone® Anti-e (RH5) - 07611969950515

Blood Grouping Reagent Anti-e (RH5); Seraclone® Human Monoclonal (MS16/MS21/MS63); for tube test; 5ml
Bio-Rad Medical Diagnostics GmbH
802370100
In Commercial Distribution

  • 07611969950515 ()
802370100

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Seraclone® Anti-E (RH3) - 07611969950430

Blood Grouping Reagent Anti-E (RH3); Seraclone® Human Monoclonal (MS260/MS12); for tube test; 5ml
Bio-Rad Medical Diagnostics GmbH
802336100
In Commercial Distribution

  • 07611969950430 ()
802336100

  • Anti-E [RH003] red blood cell grouping IVD, antibody

IgE/FITC (Polyclonal) - B502BSB301110

IgE/FITC is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative
BIO SB, INC.
BSB-3011-1
In Commercial Distribution

  • B502BSB301110 ()

  • Total Volume: 1 Milliliter
BSB-3011-1

  • Immunoglobulin E subclass (IgE subclass) IVD, antibody

Curian Shiga Toxin - 00840733103308

The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.
MERIDIAN BIOSCIENCE, INC.
760630
In Commercial Distribution

  • 00840733103308 ()
760630

  • Escherichia coli antigen IVD, kit, fluorescent immunoassay

DG Gel 8 Anti-e - 08437014205145

For the determination of human e antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210124
Not in Commercial Distribution

  • 08437014205145 ()
210124

  • Anti-E [RH005] red blood cell grouping IVD, antibody

DG Gel 8 Anti-E - 08437014205121

For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
210122
Not in Commercial Distribution

  • 08437014205121 ()
210122

  • Anti-E [RH003] red blood cell grouping IVD, antibody

MTS - 10758750005925

MTS Anti-e (small e) (Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080312
In Commercial Distribution

  • 10758750005925 ()
MTS080312

  • Anti-E [RH005] red blood cell grouping IVD, antibody

MTS - 10758750005901

MTS Anti-E (Monoclonal) Card
MICRO TYPING SYSTEMS, INC
MTS080212
In Commercial Distribution

  • 10758750005901 ()
MTS080212

  • Anti-E [RH003] red blood cell grouping IVD, antibody

BIOCLONE - 10758750003297

ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
714180
In Commercial Distribution

  • 10758750003297 ()
714180

  • Anti-E [RH005] red blood cell grouping IVD, antibody

BIOCLONE - 10758750003259

ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
713180
In Commercial Distribution

  • 10758750003259 ()
713180

  • Anti-E [RH003] red blood cell grouping IVD, antibody

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) - 23661562173192

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems
DIAGAST
17319
In Commercial Distribution

  • 23661562173192 ()
17319

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Anti-e (RH5) - 23661562105308

Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method.
DIAGAST
210530
In Commercial Distribution

  • 23661562105308 ()
  • 13661562105301 ()
210230

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Anti-E (RH3) - 23661562105292

Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) (906) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) on the surface of human red blood cells by manual tube method.
DIAGAST
210529
In Commercial Distribution

  • 23661562105292 ()
  • 13661562105295 ()
210529

  • Anti-E [RH003] red blood cell grouping IVD, antibody

Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63) - 23661562495584

Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
DIAGAST
B49558
In Commercial Distribution

  • 23661562495584 ()
B49558

  • Anti-E [RH005] red blood cell grouping IVD, antibody

Beckman Coulter® PK® Systems Anti-E (906) - 23661562173079

Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17307
In Commercial Distribution

  • 23661562173079 ()
17307

  • Anti-E [RH003] red blood cell grouping IVD, antibody

Lyphochek - 00847661005728

Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000141
In Commercial Distribution

  • 00847661005728 ()
12000141

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005759

Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005742

Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000143
In Commercial Distribution

  • 00847661005742 ()
12000143

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005735

Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000142
In Commercial Distribution

  • 00847661005735 ()
12000142

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM - 00630414979519

Allergen Specific IgE CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388502
In Commercial Distribution

  • 00630414979519 ()
L2UNCVM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control - 00630414984599

Specific IgE Neg - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485107
In Commercial Distribution

  • 00630414984599 ()
L2SNCCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 - 00630414984582

Specific IgE M6 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485106
In Commercial Distribution

  • 00630414984582 ()
MC6LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 - 00630414984575

Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 - 00630414984568

Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Positive Control Pack - 00816879029543

No Description
HYCOR BIOMEDICAL LLC
63150Z
In Commercial Distribution

  • 00816879029543 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879029536

No Description
HYCOR BIOMEDICAL LLC
63155Z
In Commercial Distribution

  • 00816879029536 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879023039

No Description
HYCOR BIOMEDICAL LLC
63155
In Commercial Distribution

  • 00816879023039 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Positive Control Pack - 00816879023022

No Description
HYCOR BIOMEDICAL LLC
63150
In Commercial Distribution

  • 00816879023022 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

SPECIFIC IGE CONTROL KIT - 00816879022063

No Description
HYCOR BIOMEDICAL LLC
71207
Not in Commercial Distribution

  • 00816879022063 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

ImmunoCard STAT! EHEC - 00840733101366

ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
MERIDIAN BIOSCIENCE, INC.
751630
In Commercial Distribution

  • 00840733101366 ()
751630

  • Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

CARDINAL HEALTH - 10888439200058

E P PACK
Cardinal Health 200, LLC
SAN35EPSTI
In Commercial Distribution

  • 50888439200056 ()
  • 10888439200058 ()
SAN35EPSTI

  • Angiography kit

ARCHITECT - 00380740054243

Quantia Immunoglobulin E
ABBOTT LABORATORIES
6K42-40
In Commercial Distribution

  • 00380740054243 ()
06K4240

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

Medline Industries, Inc. - 10888277073319

E P PACK
MEDLINE INDUSTRIES, INC.
DYNJ43898
In Commercial Distribution

  • 10888277073319 ()
DYNJ43898

  • General surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 10887488200835

CARDIAC E PACK
Cardinal Health 200, LLC
SCV19CHUWU
In Commercial Distribution

  • 50887488200833 ()
  • 10887488200835 ()
SCV19CHUWU

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488255248

LAMINECTOMY E,KIT
Cardinal Health 200, LLC
PNOCDE36O
In Commercial Distribution

  • 50887488255246 ()
  • 10887488255248 ()
PNOCDE36O

  • Embolization implant kit

CARDINAL HEALTH - 10888439105735

E P FEMORAL
Cardinal Health 200, LLC
SAN12FPYH2
In Commercial Distribution

  • 50888439105733 ()
  • 10888439105735 ()
SAN12FPYH2

  • Angiography kit

CARDINAL HEALTH - 10888439260991

E P TRAY
Cardinal Health 200, LLC
SAN41EPPH2
In Commercial Distribution

  • 50888439260999 ()
  • 10888439260991 ()
SAN41EPPH2

  • Cardiothoracic surgical procedure kit, medicated, single-use

Trident - 04546540516848

Alpha Code E
Howmedica Osteonics Corp.
625-0T-32E
In Commercial Distribution

  • 04546540516848 ()

  • Lumen/Inner Diameter: 32.0 Millimeter
  • Degree: 0.0 Degree
625-0T-32E

  • Ceramic acetabular liner
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