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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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Clinitek Novus® Cal 1-4 kit - 00630414590950

Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator

Poliomyelitis ELISA - 00404847425581

The Poliomyelitis Virus IgG ELISA has been designed for the detection and the quantitative determination of specific IgG antibodies against Polio Serotypes 1 and 3 in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2558
Not in Commercial Distribution

  • 00404847425581 ()
EIA-2558

  • Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics ™ Mumps Control Slides - 04053252364068

Mumps Control Slides
EMD Millipore Corporation
5029-5
Not in Commercial Distribution

  • 04053252364068 ()
5029-5

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

Light Diagnostics™ Mumps IFA Kit - 04053252329746

Mumps IFA Kit
EMD Millipore Corporation
3140
Not in Commercial Distribution

  • 04053252329746 ()
3140

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

Light Diagnostics ™ Mumps Monoclonal Antibody - 04053252282713

Mumps Monoclonal Antibody
EMD Millipore Corporation
5028
Not in Commercial Distribution

  • 04053252282713 ()
5028

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

Leptopspira IgG ELISA - 04048474057515

The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5751
In Commercial Distribution

  • 04048474057515 ()
EIA-5751

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Leptospira IgG ELISA - 04048474042450

The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4245
In Commercial Distribution

  • 04048474042450 ()
EIA-4245

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Brucella IgG ELISA - 04048474034554

The DRG Brucella IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Brucella in human serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3455
In Commercial Distribution

  • 04048474034554 ()
EIA-3455

  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Schistosoma Antibody 96 Tests - 00813545026455

No Description
SCIMEDX CORPORATION
SCHISTO-96
In Commercial Distribution

  • 00813545026455 ()
SCHISTO-96

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Leptospira IgG Antibody 96 Test - 00813545026318

No Description
SCIMEDX CORPORATION
LEPTO-G
In Commercial Distribution

  • 00813545026318 ()
LEPTO-G

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

LIAISON® EBNA IgG Serum Control Set - 08056771601788

No Description
DIASORIN SPA
310522
Not in Commercial Distribution

  • 08056771601788 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

LIAISON® EBNA IgG Serum Control Set - 08056771102988

No Description
DIASORIN SPA
310522
In Commercial Distribution

  • 08056771102988 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control EBNA IgG - 08056771101776

No Description
DIASORIN SPA
310521
In Commercial Distribution

  • 08056771101776 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control

AccuDiag ™ - 00894175000114

AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8209-35
In Commercial Distribution

  • 00894175000114 ()

  • 96 Tests
8209-35

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS POLIOVIRUS IgG - 08033891329631

No Description
DIESSE DIAGNOSTICA SENESE SPA
81264
In Commercial Distribution

  • 08033891329631 ()
81264

  • Poliovirus immunoglobulin G (IgG) antibody (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)

Schistosoma mansoni IgG ELISA - 07640158219607

The Schistosoma mansoni ELISA test is a qualitative enzyme immunoassay for the detection of Schistosoma mansoni and Schistosoma haematobium antibodies in human serum samples.
Bordier affinity products S.A.
9600
In Commercial Distribution

  • 07640158219607 ()
9600

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Toxoplasma gondii Control Slides - B502BSB9416CS0

Toxoplasma gondii Control Slides
BIO SB, INC.
BSB-9416-CS
In Commercial Distribution

  • B502BSB9416CS0 ()
BSB-9416-CS

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Toxoplasma gondii control slides - B502BSB60490

Toxoplasma gondii , control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB60490 ()
BSB 6049

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Diamedix - 00817273020419

"720-850 Mycoplasma IgG Test Kit"
DIAMEDIX CORPORATION
720-850
In Commercial Distribution

  • 00817273020419 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020402

"720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-830
In Commercial Distribution

  • 00817273020402 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

IMMY - 00816387021152

No Description
Immuno-Mycologics, Inc.
CTA2003
In Commercial Distribution

  • 00816387021152 ()
  • 00816387021169 ()


  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System - B110ME60060

No Description
Bion Enterprises, Ltd.
ME-6006
Not in Commercial Distribution

  • B110ME60060 ()
ME-6006

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent

Mumps Virus Antigen Substrate, 12 wells, For IFA Test System - B110MU80120

No Description
Bion Enterprises, Ltd.
MU-8012
In Commercial Distribution

  • B110MU80120 ()
MU-8012

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent

Mumps Virus Antigen Substrate, 6 wells, For IFA Test System - B110MU80060

No Description
Bion Enterprises, Ltd.
MU-8006
Not in Commercial Distribution

  • B110MU80060 ()
MU-8006

  • Mumps virus immunoglobulin G (IgG) antibody IVD, reagent

Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test System - B110ME60120

No Description
Bion Enterprises, Ltd.
ME-6012
In Commercial Distribution

  • B110ME60120 ()
ME-6012

  • Measles virus immunoglobulin G (IgG) antibody IVD, reagent

Adenovirus Antigen Substrate, 12 wells, For IFA Test System - B110AD31120

No Description
Bion Enterprises, Ltd.
AD-3112
In Commercial Distribution

  • B110AD31120 ()
AD-3112

  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Henry Schein - 10304040127879

Ear Washer - Rigid Tube, 3 Tips, IFU
HENRY SCHEIN, INC.
5701885
In Commercial Distribution

  • 00304040127872 ()
  • 10304040127879 ()
5701885

  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Henry Schein - 10304040130909

Splash Shields for Ear Wash system Ridged Tube
HENRY SCHEIN, INC.
5701917
In Commercial Distribution

  • 00304040130902 ()
  • 10304040130909 ()
5701917

  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Parainfluenza Virus 1, 2, 3 IgG - ENTIPAIG03600

The Parainfluenza Virus 1, 2, 3 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Parainfluenza Virus 1, 2, 3 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
PAIG0360
In Commercial Distribution

  • ENTIPAIG03600 ()
PAIG0360

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Leptospira IgG - ENTILEPG06600

The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
Gold Standard Diagnostics Frankfurt GmbH
LEPG0660
In Commercial Distribution

  • ENTILEPG06600 ()
LEPG0660

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Brucella IgG - ENTIBRUG00500

The Brucella IgG ELISA is intended for the qualitative determination of IgG class antibodies against Brucella in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
BRUG0050
In Commercial Distribution

  • ENTIBRUG00500 ()
BRUG0050

  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EBV Negative Control - B110EBN50100

No Description
Bion Enterprises, Ltd.
EBN-5010
In Commercial Distribution

  • B110EBN50100 ()
EBN-5010

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

OSOM COVID-19 Antigen Control Kit - 00742860000034

OSOM COVID-19 Antigen Control Kit
SEKISUI DIAGNOSTICS, LLC
1068
In Commercial Distribution

  • 00742860000034 ()
  • 10742860000031 ()
1068

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

MAS SARS-CoV-2 IgG Positive Control - 00884883007765

No Description
Microgenics Corporation
10028305
In Commercial Distribution

  • 00884883007765 ()


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

Isotype Reagent Mo IgG1/APC - 05700572516682

Isotype Reagent Mouse IgG1/APC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0968
In Commercial Distribution

  • 05700572516682 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Isotype Reagent Mo IgG2a/RPE - 05700572516620

Isotype Reagent Mouse IgG2a/RPE
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0950
In Commercial Distribution

  • 05700572516620 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

TO DISCONTINUE IN US: Isotype Reagent Mo IgG2b/FITC - 05700572516606

Isotype Reagent Mouse IgG2b/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0941
In Commercial Distribution

  • 05700572516606 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Isotype Reagent Mo IgG2a/FITC - 05700572516576

Isotype Reagent Mouse IgG2a/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0933
In Commercial Distribution

  • 05700572516576 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

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 - 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 - M684730028581

LINEAGE® CERAMIC LINER 28mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73002858
In Commercial Distribution

  • 73002858 ()
  • M684730028581 ()

  • Lumen/Inner Diameter: 28 Millimeter
73002858

  • Ceramic acetabular liner

Lineage - M684720032521

LINEAGE® CERAMIC LINER 32mm X 52-56mm GROUP 2
Microport Orthopedics Inc.
72003252
In Commercial Distribution

  • 72003252 ()
  • M684720032521 ()

  • Lumen/Inner Diameter: 32 Millimeter
72003252

  • Ceramic acetabular liner

Lineage - M684720028521

LINEAGE® CERAMIC LINER 28mm X 52-56mm GROUP 2
Microport Orthopedics Inc.
72002852
In Commercial Distribution

  • 72002852 ()
  • M684720028521 ()

  • Lumen/Inner Diameter: 28 Millimeter
72002852

  • 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 - 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

Lineage - M684710028461

LINEAGE® CERAMIC LINER 28mm X 46-50mm GROUP 1
Microport Orthopedics Inc.
71002846
In Commercial Distribution

  • 71002846 ()
  • M684710028461 ()

  • Lumen/Inner Diameter: 28 Millimeter
71002846

  • 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)
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