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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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ALBAclone Anti-Leb - 05060242471049

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

N/A - 00382903492091

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)

Fungal Serology - 10634853000022

Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000015

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

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

Bordetella Pertussis IgG - 07290016332636

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)

OSOM Influenza Control Kit - 00742860100147

No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control

OSOM ULTRA PLUS FLU A&B Control Kit - 00742860100406

No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control

Acucy Influenza A&B Control Kit - 00742860100383

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 - 00742860100215

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

Validate - 00850011135495

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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