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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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SCIg60 Infusion System - 00817708020274

SCIg60 Infuser (Mechanical Pump) Assembly
EMED TECHNOLOGIES CORPORATION
FP-0010002
In Commercial Distribution

  • 00817708020274 ()
FP-0010002

  • Ambulatory non-insulin infusion pump, mechanical, reusable

Hydrashift 2 4 isatuximab - 03607360046425

No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent

HYDRASHIFT 2 4 daratumumab 20 tests - 03607360046395

No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent

Sample Diluent CAPI 3 IT (10) - 03607360026021

No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent

ANTISERA CAPI 3 IT (10) - 03607360026014

No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent

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)

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

STRADIS HEALTHCARE - M752ZZ07000

HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control

SeraQuest - 00850487007531

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H.pylori G
In Commercial Distribution

  • 00850487007531 ()
01550Q-1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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