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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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K-ASSAY® IgM Reagent - 00816426020115

For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-015
In Commercial Distribution

  • 00816426020115 ()
KAI-015

  • Total immunoglobulin M (IgM total) IVD, reagent

K-ASSAY® IgA Reagent - 00816426020092

For the quantitative determination of human IgA in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-013
In Commercial Distribution

  • 00816426020092 ()
KAI-013

  • Total immunoglobulin A (IgA total) IVD, reagent

Antiserum to Human IgG, IgA and IgM - B1761160

No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761160 ()
116002

  • Total immunoglobulin G (IgG total) IVD, control

CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 - 00817302020953

IgM (Immunoglobulin M) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC638
Not in Commercial Distribution

  • 00817302020953 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC638

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

JBAIDS - 00851458005082

JBAIDS IVD Influenza A/H5 Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0136
Not in Commercial Distribution

  • 00851458005082 ()
JRPD-ASY-0136

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II - 05051700016919

No Description
THE BINDING SITE GROUP LIMITED
NK623.T.A
In Commercial Distribution

  • 05051700016919 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Micro-Forceps CROSS MAX - 00883475953176

No Description
CHARMANT INC.
30-0702
In Commercial Distribution

  • 00883475953176 ()


  • Surgical A/V-shaped microvessel clamp

Micro-Forceps CROSS MAX - 00883475953121

No Description
CHARMANT INC.
30-0701
In Commercial Distribution

  • 00883475953121 ()


  • Surgical A/V-shaped microvessel clamp

FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTU (Dako Omnis) - 05700572034179

FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Omnis)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GA605
In Commercial Distribution

  • 05700572034179 ()

  • Total Volume: 12 Milliliter


  • Amyloid A component IVD, antibody

FLEX Mono Mo A-Hu Amyloid A Cl mc1 RTU - 05700572030331

FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS605
In Commercial Distribution

  • 05700572030331 ()

  • 20-30 Tests


  • Amyloid A component IVD, antibody
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