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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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No Description
Roche Diagnostics GmbH
5572185160
In Commercial Distribution

  • 04015630939046 ()
5572185160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Detection of Herpes Simplex 1 and 2 Antibodies
ARLINGTON SCIENTIFIC, INC.
NC-830096-AG
In Commercial Distribution

  • 00816057020577 ()

  • 96 Test
NC-830096-AG

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08948852190
In Commercial Distribution

  • 07613336170656 ()
08948852190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948887160
In Commercial Distribution

  • 07613336170694 ()
08948887160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948909190
In Commercial Distribution

  • 07613336170687 ()
08948909190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948844160
In Commercial Distribution

  • 07613336170663 ()
08948844160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.
POINTE SCIENTIFIC, INC.
T8007-96
In Commercial Distribution

  • 00811727015211 ()
T8007-96

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.
Gold Standard Diagnostics Corporation
720-340
In Commercial Distribution

  • B3507203400 ()
720-340

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6725-300
In Commercial Distribution

  • 00816870024332 ()

  • Width: 7.75 Inch
6725-300B

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56150 ()
BSB 5615

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56110 ()
BSB 5611

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56140 ()
BSB 5614

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56130 ()
BSB 5613

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56120 ()
BSB 5612

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56100 ()
BSB 5610

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
No Description
DIASORIN MOLECULAR LLC
IB0900G
In Commercial Distribution

  • 20816101021004 ()
IB0900G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Captia™ Chlamydia IgG
CLARK LABORATORIES, INC.
2346200
In Commercial Distribution

  • 05391516743952 ()

  • 96 Tests
2346200

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5645
In Commercial Distribution

  • 00840239056450 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5645
In Commercial Distribution

  • 04048474056457 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
ID Candida Antibody System
Immuno-Mycologics, Inc.
CA1001
In Commercial Distribution

  • 00816387020797 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
Candida ID Positive Control
Immuno-Mycologics, Inc.
C60110
In Commercial Distribution

  • 00816387020230 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
Candida ID Antigen
Immuno-Mycologics, Inc.
C50110
In Commercial Distribution

  • 00816387020223 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent
No Description
AALTO SCIENTIFIC
K087M-6
In Commercial Distribution

  • B085K087M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
AALTO SCIENTIFIC
K077M-6
In Commercial Distribution

  • B085K077M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
Bion Enterprises, Ltd.
P3-9112
Not in Commercial Distribution

  • B110P391120 ()
P3-9112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P2-8112
Not in Commercial Distribution

  • B110P281120 ()
P2-8112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P1-7112
Not in Commercial Distribution

  • B110P171120 ()
P1-7112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
EliA SARS-CoV-2-Sp1 IgG Well
Phadia AB
DECC066630
In Commercial Distribution

  • 07333066021201 ()
  • 07333066021287 ()
DECC066630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Sample Diluent/Wash Powder , 5g
MARDX DIAGNOSTICS, INC.
40-2030
In Commercial Distribution

  • 05391516749152 ()
40-2030

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
T. pallidum Marblot Strip, 20 each pack
MARDX DIAGNOSTICS, INC.
40-5018
In Commercial Distribution

  • 05391516749114 ()
40-5018

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
FITC Parasite IgG Conjugate (Rodent), 4.0 mL
MARDX DIAGNOSTICS, INC.
20-90215
In Commercial Distribution

  • 05391516748872 ()
20-90215

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, reagent
T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests
MARDX DIAGNOSTICS, INC.
40-5020G
In Commercial Distribution

  • 05391516748704 ()
40-5020G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
A76101G
In Commercial Distribution

  • 00845533000116 ()
A76101G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For use with ImmunoFA Toxoplasma kits
Genbio
800-1207
In Commercial Distribution

  • 00613745012070 ()

  • 100 slides, 10 tests per slide
1207

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