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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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VITROS Immunodiagnostic Products Anti-HBc Controls
ORTHO CLINICAL DIAGNOSTICS
6801430
In Commercial Distribution

  • 10758750001231 ()
  • 20758750001238 ()
6801430

  • Hepatitis B virus core total antibody IVD, control
No Description
DIASORIN SPA
318220
In Commercial Distribution

  • 08056771103442 ()


  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
318160
In Commercial Distribution

  • 18056771103425 ()
  • 08056771103428 ()


  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
318131
In Commercial Distribution

  • 08056771103374 ()
  • 28056771103378 ()


  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
04927931162
In Commercial Distribution

  • 07613336183199 ()
04927931162

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
09367039190
In Commercial Distribution

  • 07613336183021 ()
09367039190

  • Hepatitis B virus core total antibody IVD, control
Blood Grouping Reagent Anti-Jkb (JK2); Seraclone® Human Monoclonal (MS8); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808184100
In Commercial Distribution

  • 07611969951796 ()
808184100

  • Anti-Jk^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal) (GX336) - This reagent is designed to determine the presence of the blood group antigen Leb (LE2) on the surface of human red blood cells by manual tube method.
DIAGAST
210542
In Commercial Distribution

  • 23661562105421 ()
210542

  • Anti-Le^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method.
DIAGAST
210535
In Commercial Distribution

  • 23661562105353 ()
210535

  • Anti-Jk^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) (SpA264LBg1) - This reagent is designed to determine the presence of the blood group antigen Fyb (FY2) on the surface of human red blood cells by manual tube method.
DIAGAST
210532
In Commercial Distribution

  • 23661562105322 ()
210532

  • Anti-Fy^b red blood cell grouping IVD, antibody
Blood Grouping Reagent, ALBAclone Anti-Leb (Murine Monoclonal IgM) for tube technique.
ALBA BIOSCIENCE LIMITED
Z217U
In Commercial Distribution

  • 05060242471049 ()


  • Anti-Le^b red blood cell grouping IVD, antibody
BD® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution

  • 00382903492091 ()
349209

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control
Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • Influenza A/B virus antigen IVD, control
OSOM Ultra Flu A&B Controls 5 Test
SEKISUI DIAGNOSTICS, LLC
1005
In Commercial Distribution

  • 00742860100215 ()
  • 10742860100212 ()
1005

  • Influenza A/B virus antigen IVD, control
aHBs Calibration Verification / Linearity Test kit
Lgc Clinical Diagnostics, Inc.
801mm
In Commercial Distribution

  • 00850011135495 ()


  • Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control
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