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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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Rabbit Monoclonal Anti-Human IgA (170), 1 mL concentrated
Epitomics Inc.
AC-0147
In Commercial Distribution

  • 00810113063843 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Rabbit Monoclonal Anti-Human IgA (170), 0.5 mL concentrated
Epitomics Inc.
AC-0147B
In Commercial Distribution

  • 00810113063836 ()

  • Total Volume: 0.5 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Control swabs intended for use only with Strep A product.
Alere Scarborough, Inc.
730-010
In Commercial Distribution

  • 10811877010446 ()


  • Beta-haemolytic Group A Streptococcus 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
No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control
Rabbit Monoclonal Anti-Human IgA (170), 0.1 mL concentrated
Epitomics Inc.
AC-0147A
In Commercial Distribution

  • 00810113063850 ()

  • Total Volume: 0.1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Linearity Standard Set A
NOVA BIOMEDICAL CORPORATION
A
In Commercial Distribution

  • 00385480252171 ()
  • 00385489252172 ()
25217

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
LINEARITY STANDARD SET A
NOVA BIOMEDICAL CORPORATION
A
In Commercial Distribution

  • 00385480140713 ()
14071

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
To provide support for a patient’s head in the prone position.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187718 ()
AM0710

  • Operating table patient positioning set, reusable
Head Immobiliser Hood Assembly and Strap
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187657 ()
AM0820

  • Operating table patient positioning set, reusable
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