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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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ARCHITECT - 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit
Abbott Ireland Diagnostics
06S6010
In Commercial Distribution

  • 00380740193744 ()
06S6010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740192112

SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R9010
In Commercial Distribution

  • 00380740192112 ()
06R9010

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ARCHITECT - 00380740191825

SARS-CoV-2 IgG Control Kit
ABBOTT LABORATORIES
06R8610
In Commercial Distribution

  • 00380740191825 ()
06R8610

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Trident - 04546540259936

Alpha Code I
Howmedica Osteonics Corp.
625-0T-36I
In Commercial Distribution

  • 04546540259936 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 36.0 Millimeter
625-0T-36I

  • Ceramic acetabular liner

Trident - 04546540516879

Alpha Code H
Howmedica Osteonics Corp.
625-0T-36H
In Commercial Distribution

  • 04546540516879 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 36.0 Millimeter
625-0T-36H

  • Ceramic acetabular liner

Trident - 04546540516862

Alpha Code G
Howmedica Osteonics Corp.
625-0T-36G
In Commercial Distribution

  • 04546540516862 ()

  • Lumen/Inner Diameter: 36.0 Millimeter
  • Degree: 0.0 Degree
625-0T-36G

  • Ceramic acetabular liner

Trident - 04546540516855

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

  • 04546540516855 ()

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

  • Ceramic acetabular liner

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

Trident - 04546540516831

Alpha Code D
Howmedica Osteonics Corp.
625-0T-28D
In Commercial Distribution

  • 04546540516831 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 28.0 Millimeter
625-0T-28D

  • Ceramic acetabular liner

Measles Virus IgG Avidity ELISA - 00404847459678

The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5967
Not in Commercial Distribution

  • 00404847459678 ()
EIA-5967

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

N AS IgG2 - 00842768008467

Quantitative determination of IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N AS IgG1 - 00842768008450

Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N Latex IgG3 - 00842768006708

Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445972
In Commercial Distribution

  • 00842768006708 ()
OPAV03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

N Latex IgG4 - 00842768006692

Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Immunoglobulin G Subclass 4 Flex® Reagent Cartridge - 00842768006296

For the quantitative measurement of immunoglobulin G subclass 4 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445914
In Commercial Distribution

  • 00842768006296 ()
  • 00842768020230 ()
K7083

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge - 00842768006289

For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Immunoglobulin G Subclass 2 Flex® reagent cartridge - 00842768006272

For the quantitative measurement of immunoglobulin G subclass 2 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445912
In Commercial Distribution

  • 00842768006272 ()
  • 00842768020193 ()
K7081

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

DImension Vista® Immunoglobulin G Subclass 1 Flex® reagent cartridge - 00842768006265

For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445911
In Commercial Distribution

  • 00842768006265 ()
  • 00842768020186 ()
K7080

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

BioPlex 2200 - 00847865000932

HSV-1 & HSV-2 Control Lot Data
BIO-RAD LABORATORIES, INC.
6633340
In Commercial Distribution

  • 00847865000932 ()

  • 1 Each
6633340

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 - 00847865000925

HSV-1 & HSV-2 IgG Control Set
BIO-RAD LABORATORIES, INC.
6633330
In Commercial Distribution

  • 00847865000925 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6633330

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

DV/DM COV2G/CV2G POS/NEG CTRL - 00630414607054

DV/DM COV2G/CV2G POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417773
Not in Commercial Distribution

  • 00630414298405 ()
  • 00630414607054 ()
KC873

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Tetanus Toxoid IgG Conjugate - 05051700019613

No Description
THE BINDING SITE GROUP LIMITED
EA118.A
In Commercial Distribution

  • 05051700019613 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, reagent

AccuDiag™ - 00894175000527

AccuDiag™Measles IgM ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Measles virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD 1409-1
In Commercial Distribution

  • 00894175000527 ()

  • 96 Tests
1409-1

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

VITROS - 10758750033379

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199921
In Commercial Distribution

  • 10758750033379 ()
6199921

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

ORTHO - 10758750007875

T. CRUZI ELISA TEST SYSTEM 192T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902594
In Commercial Distribution

  • 10758750007875 ()
6902594

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ORTHO - 10758750007745

T. CRUZI ELISA TEST SYSTEM 192T WW
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902412
In Commercial Distribution

  • 10758750007745 ()
6902412

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ORTHO - 10758750007479

T.CRUZI ELISA Test System 2400T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901969
In Commercial Distribution

  • 10758750007479 ()
6901969

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ORTHO - 10758750007462

T.CRUZI ELISA Test System 480T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901968
In Commercial Distribution

  • 10758750007462 ()
6901968

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

VITROS - 10758750034550

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199974
In Commercial Distribution

  • 20758750034557 ()
  • 10758750034550 ()
6199974

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Delta Dual Mobility System - 08033390086332

Liner #M for Mobile Liner Dia. 40 mm
LIMACORPORATE SPA
5885.09.040
In Commercial Distribution

  • 08033390086332 ()

  • #M Dia. 40 mm
5885.09.040

  • Ceramic acetabular liner

Delta Dual Mobility System - 08033390020060

Liner #L for Mobile Liner Dia. 42 mm
LIMACORPORATE SPA
5885.09.042
In Commercial Distribution

  • 08033390020060 ()

  • #L Dia. 42 mm
5885.09.042

  • Ceramic acetabular liner

Measles Virus IgG Avidity ELISA - 00840239059673

The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
DRG International Inc
EIA-5967
Not in Commercial Distribution

  • 00840239059673 ()
EIA-5967

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Mumps IgM ELISA - 00840239038470

The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3847
In Commercial Distribution

  • 00840239038470 ()
EIA-3847

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Mumps Virus IgG ELISA - 00840239038463

The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3846
In Commercial Distribution

  • 00840239038463 ()

  • Conjugate
  • Diluent G
  • Total Volume: 20 Milliliter
  • Wash Buffer
  • Cut Off
  • Total Volume: 100 Milliliter
  • Total Volume: 15 Milliliter
  • Total Volume: 50 Milliliter
  • Total Volume: 3 Milliliter
  • Stop Solution
  • Controls +/-
  • Substrate TMB
  • Total Volume: 2 Milliliter
EIA-3846

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Measles Virus IgG ELISA - 00840239038449

The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3844
In Commercial Distribution

  • 00840239038449 ()

  • Total Volume: 2 Milliliter
  • Substrate TMB
  • Cut Off
  • Total Volume: 50 Milliliter
  • Total Volume: 3 Milliliter
  • Conjugate
  • Controls +/-
  • Total Volume: 20 Milliliter
  • Total Volume: 15 Milliliter
  • Diluent G
  • Stop Solution
  • Wash Buffer
  • Total Volume: 100 Milliliter
EIA-3844

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Lineage - M684740036641

LINEAGE® CERAMIC LINER 36mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74003664
In Commercial Distribution

  • 74003664 ()
  • M684740036641 ()

  • Lumen/Inner Diameter: 36 Millimeter
74003664

  • Ceramic acetabular liner

Lineage - M684740032641

LINEAGE® CERAMIC LINER 32mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74003264
In Commercial Distribution

  • 74003264 ()
  • M684740032641 ()

  • Lumen/Inner Diameter: 32 Millimeter
74003264

  • Ceramic acetabular liner

Lineage - M684740028641

LINEAGE® CERAMIC LINER 28mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74002864
In Commercial Distribution

  • 74002864 ()
  • M684740028641 ()

  • Lumen/Inner Diameter: 28 Millimeter
74002864

  • Ceramic acetabular liner

Lineage - M684730036581

LINEAGE® CERAMIC LINER 36mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73003658
In Commercial Distribution

  • 73003658 ()
  • M684730036581 ()

  • Lumen/Inner Diameter: 36 Millimeter
73003658

  • Ceramic acetabular liner

Lineage - M684730032581

LINEAGE® CERAMIC LINER 32mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73003258
In Commercial Distribution

  • 73003258 ()
  • M684730032581 ()

  • Lumen/Inner Diameter: 32 Millimeter
73003258

  • Ceramic acetabular liner
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