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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VITROS Immunodiagnostic Products Anti-HBc Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801429
In Commercial Distribution

  • 10758750001224 ()
  • 20758750001221 ()
6801429

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801428
In Commercial Distribution

  • 10758750001217 ()
  • 20758750001214 ()
6801428

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801426
In Commercial Distribution

  • 10758750001194 ()
6801426

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801425
In Commercial Distribution

  • 10758750001187 ()
6801425

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBsAg Confirmatory Kit
ORTHO CLINICAL DIAGNOSTICS
6801324
In Commercial Distribution

  • 10758750001088 ()
  • 20758750001085 ()
6801324

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBsAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801323
In Commercial Distribution

  • 10758750001071 ()
  • 20758750001078 ()
6801323

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801322
In Commercial Distribution

  • 10758750001064 ()
  • 20758750001061 ()
6801322

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820524160
Not in Commercial Distribution

  • 04015630919420 ()
11820524160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 04015630999286 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
07251076190
Not in Commercial Distribution

  • 04015630940028 ()
07251076190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control
No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876376160
Not in Commercial Distribution

  • 04015630934843 ()
11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution

  • 04015630939862 ()
07027427190

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931160
Not in Commercial Distribution

  • 04015630923045 ()
04927931160

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
04927826160
Not in Commercial Distribution

  • 04015630923038 ()
04927826160

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08498610160
In Commercial Distribution

  • 07613336230367 ()
08498610160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09014926160
In Commercial Distribution

  • 07613336203613 ()
09014926160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09014918160
In Commercial Distribution

  • 07613336203606 ()
09014918160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08498598160
In Commercial Distribution

  • 07613336160367 ()
08498598160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs CC 3 Elecsys
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 07613336159804 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
11876317160
In Commercial Distribution

  • 07613336159798 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
11820524160
In Commercial Distribution

11820524160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876333160
In Commercial Distribution

11876333160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
No Description
Roche Diagnostics GmbH
11820567160
In Commercial Distribution

11820567160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876376160
In Commercial Distribution

11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
11820583160
In Commercial Distribution

11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08343594160
In Commercial Distribution

  • 07613336154014 ()
08343594160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931161
In Commercial Distribution

  • 07613336153949 ()
04927931161

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
07026811160
In Commercial Distribution

  • 07613336153932 ()
07026811160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026790160
Not in Commercial Distribution

  • 07613336153925 ()
07026790160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07374160160
Not in Commercial Distribution

  • 07613336142295 ()
07374160160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814856160
In Commercial Distribution

  • 07613336198285 ()
08814856160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814864160
Not in Commercial Distribution

  • 07613336198278 ()
08814864160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741034190
In Commercial Distribution

  • 07613336172902 ()
08741034190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814848190
In Commercial Distribution

  • 07613336168103 ()
08814848190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741107190
In Commercial Distribution

  • 07613336164372 ()
08741107190

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
04687876160
In Commercial Distribution

  • 07613336106402 ()
04687876160

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
07914482160
Not in Commercial Distribution

  • 07613336106396 ()
07914482160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBs EIA, Conjugate Diluent 15 mL
Bio-RAD Laboratories, Inc.
26155
In Commercial Distribution

  • 00847865002103 ()

  • Total Volume: 15 Milliliter
26155

  • Hepatitis B virus surface total antibody IVD, reagent
HBsAg EIA 3.0 Conjugate Diluent, 120 mL
Bio-RAD Laboratories, Inc.
25104
In Commercial Distribution

  • 00847865001861 ()

  • Total Volume: 120 Milliliter
25104

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
MARDX DIAGNOSTICS, INC.
40-6196P
In Commercial Distribution

  • 05391516747899 ()
40-6196P

  • Bordetella pertussis total antibody IVD, kit, immunoblot
B. pertussis WB Negative Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-6111
In Commercial Distribution

  • 05391516747882 ()
40-6111

  • Bordetella pertussis total antibody IVD, control
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