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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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STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - B126KR60100

A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR6010
In Commercial Distribution

  • B126KR60100 ()
KR6010

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay

Cathepsin K Control Slides - B502BSB9438CS0

Cathepsin K Control Slides
BIO SB, INC.
BSB-9438-CS
In Commercial Distribution

  • B502BSB9438CS0 ()
BSB-9438-CS

  • Cathepsin IVD, control

IgG4 Control Slides - B502BSB9237CS0

IgG4 Control Slides
BIO SB, INC.
BSB-9237-CS
In Commercial Distribution

  • B502BSB9237CS0 ()
BSB-9237-CS

  • Immunoglobulin G subclass (IgG subclass) IVD, control

IgG Control Slides - B502BSB9236CS0

IgG Control Slides
BIO SB, INC.
BSB-9236-CS
In Commercial Distribution

  • B502BSB9236CS0 ()
BSB-9236-CS

  • Immunoglobulin G subclass (IgG subclass) IVD, control

Helicobacter pylori control slides - B502BSB56090

Helicobacter pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56090 ()
BSB 5609

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

NovaLisa Adenovirus IgG - ENTIADVG00100

The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Adenovirus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ADVG0010
In Commercial Distribution

  • ENTIADVG00100 ()
ADVG0010

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Tinto Cathepsin K (BSB-172) - B502BSB3800150

Tinto Cathepsin K is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3800-15
In Commercial Distribution

  • B502BSB3800150 ()

  • Total Volume: 15 Milliliter
BSB-3800-15

  • Cathepsin IVD, antibody

Unimed - 06945664853026

Disposable NIBP Cuff/TPU/Double tube/大Adult/with BD08 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1620D-C0808-05
In Commercial Distribution

  • 16945664853023 ()
  • 06945664853026 ()


  • Blood pressure cuff, single-use

Unimed - 06945664852227

Disposable NIBP Cuff/Textile/Single tube/大Adult/with BP17 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1720S-C17-05
In Commercial Distribution

  • 16945664852224 ()
  • 06945664852227 ()


  • Blood pressure cuff, single-use

Unimed - 06945664854382

Disposable NIBP Cuff/Textile/Double tube/大Adult/with BP12-P connector/Sage Services GROUP
Unimed Medical Supplies, Inc.
DC720D-C12
In Commercial Distribution

  • 06945664854382 ()


  • Blood pressure cuff, single-use

Unimed - 06945664853972

Disposable NIBP Cuff/TPU/Single tube/大Adult/with BP12 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1620S-C12-05
In Commercial Distribution

  • 16945664853979 ()
  • 06945664853972 ()


  • Blood pressure cuff, single-use

Unimed - 06945664810432

Reusable SpO2 Sensor/Philips/大号Soft finger cover/Adult/3.0M/087/Tracelogix Corporation
Unimed Medical Supplies, Inc.
TL122113A300B-CA652
In Commercial Distribution

  • 06945664810432 ()


  • Pulse oximeter probe, reusable

iFlash-Mycoplasma pn. IgG - 06925912719199

No Description
Shenzhen YHLO Biotech Co., Ltd.
C88003G
In Commercial Distribution

  • 06925912719199 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

SeraQuest - 00850487007579

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MUMPS G
In Commercial Distribution

  • 00850487007579 ()
Q01-200

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007388

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
RUB G
In Commercial Distribution

  • 00850487007388 ()
Q01-100

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007357

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MEAS G
In Commercial Distribution

  • 00850487007357 ()
Q01-190

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007319

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
CMV G
In Commercial Distribution

  • 00850487007319 ()
Q01-140

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007210

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
CMV G
In Commercial Distribution

  • 00850487007210 ()
Q01-140

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007111

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MEAS G
In Commercial Distribution

  • 00850487007111 ()
Q01-190

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007098

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
MUMPS G
In Commercial Distribution

  • 00850487007098 ()
Q01-200

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007074

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
RUB G
In Commercial Distribution

  • 00850487007074 ()
Q01-100

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747127

Captia™ Measles IgG
CLARK LABORATORIES, INC.
2326001
In Commercial Distribution

  • 05391516747127 ()

  • 480 Tests
2326001

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747110

Captia™ Mumps IgG
CLARK LABORATORIES, INC.
2325901
In Commercial Distribution

  • 05391516747110 ()

  • 480 Tests
2325901

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747004

Captia™ Rubella IgG
CLARK LABORATORIES, INC.
2325301
In Commercial Distribution

  • 05391516747004 ()

  • 480 Tests
2325301

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746984

Captia™ Cytomegalovirus (CMV) IgG
CLARK LABORATORIES, INC.
2325201
In Commercial Distribution

  • 05391516746984 ()

  • 480 Tests
2325201

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743631

Captia™ Measles IgG
CLARK LABORATORIES, INC.
2326000
In Commercial Distribution

  • 05391516743631 ()

  • 96 Tests
2326000

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743600

Captia™ Mumps IgG
CLARK LABORATORIES, INC.
2325900
In Commercial Distribution

  • 05391516743600 ()

  • 96 Tests
2325900

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743433

Captia™ Rubella IgG
CLARK LABORATORIES, INC.
2325300
In Commercial Distribution

  • 05391516743433 ()

  • 96 Tests
2325300

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743402

Captia™ Cytomegalovirus (CMV) IgG
CLARK LABORATORIES, INC.
2325200
In Commercial Distribution

  • 05391516743402 ()

  • 96 Tests
2325200

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QMedix™ - 00850054026156

QMedix™ Measles IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibodies to Measles (Rubeola) virus in human sera.
Diagnostic Automation, Inc.
DACD1408-1
In Commercial Distribution

  • 00850054026156 ()

  • 96 Tests/Kit
1408-1

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QMedix™ - 00850054026019

QMedix™ Rubella IgG ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1301-1
In Commercial Distribution

  • 00850054026019 ()

  • 96 tests
1301-1

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Measles IgG Smart Kit Test System - 00845533000833

The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9271G
In Commercial Distribution

  • 00845533000833 ()
SM9Z9271G

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Measles IgG Bulk Test System - 00845533000819

The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9271GB
In Commercial Distribution

  • 00845533000819 ()
9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Measles IgG Test System - 00845533000802

The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9271G
In Commercial Distribution

  • 00845533000802 ()
9Z9271G

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Mumps IgG Test System - 00845533000864

The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of Mumps infections.
ZEUS SCIENTIFIC, INC.
9Z9281G
In Commercial Distribution

  • 00845533000864 ()
9Z9281G

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Measles IgG Q Test System - 00845533000826

The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9271GB
In Commercial Distribution

  • 00845533000826 ()
Q9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA CMV IgG Q Test System - 00845533000383

The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
Q9Z9501GB
In Commercial Distribution

  • 00845533000383 ()
Q9Z9501GB

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA CMV IgG Smart Kit Test System - 00845533000376

The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
SM9Z9501G
In Commercial Distribution

  • 00845533000376 ()
SM9Z9501G

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA CMV IgG Test System - 00845533000369

The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
9Z9501G
In Commercial Distribution

  • 00845533000369 ()
9Z9501G

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ - 00850049545686

AccuDiag ™Rubella IgG Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro diagnostic detection and determination of IgG antibody to rubella virus in human sera.
Diagnostic Automation, Inc.
DACD1301-1
In Commercial Distribution

  • 00850049545686 ()

  • 96 tests
1301-1

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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