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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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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
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
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 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)
Lipoprotein a (LP(a)) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099433
In Commercial Distribution

  • 00630414597546 ()
11099433

  • Lipoprotein A IVD, calibrator
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446038
In Commercial Distribution

  • 00842768007224 ()
  • 00842768019111 ()
OQCV05

  • Lipoprotein A IVD, calibrator
Serum Calibration Standard ß-Carotene
Chromsystems Instruments + Chemicals GmbH
32003
In Commercial Distribution

  • 04250317505804 ()
  • 04250317543547 ()

  • 5 x 0.5ml
32003

  • Vitamin A IVD, calibrator
Lp(a) Control
ABBOTT LABORATORIES
5P84-10
In Commercial Distribution

  • 00380740100933 ()
05P8410

  • Lipoprotein A IVD, control
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