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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 use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K204C-10M
In Commercial Distribution

  • 00816426021013 ()
K204C-10M

  • Multiple coagulation factor IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K104C-10M
Not in Commercial Distribution

  • 00816426020924 ()
K104C-10M

  • Multiple coagulation factor IVD, control
For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-206C
In Commercial Distribution

  • 00816426020764 ()
KAI-206C

  • Coagulation factor XIII IVD, calibrator
For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-106C
In Commercial Distribution

  • 00816426020719 ()
KAI-106C

  • Coagulation factor XIII IVD, calibrator
For the quantitative determination of human coagulation factor XIII in plasma.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-205
In Commercial Distribution

  • 00816426020535 ()
KAI-205

  • Coagulation factor XIII IVD, reagent
For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-105
In Commercial Distribution

  • 00816426020467 ()
KAI-105

  • Coagulation factor XIII IVD, reagent
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated
Hemodialysis Pack
ARGON MEDICAL DEVICES, INC.
500326D
Not in Commercial Distribution

  • 20886333215847 ()
  • 00886333215843 ()
500326D

  • General surgical procedure kit, medicated
Acute Hemodialysis Tray
ARGON MEDICAL DEVICES, INC.
500320F
Not in Commercial Distribution

  • 20886333215830 ()
  • 00886333215836 ()
500320F

  • General surgical procedure kit, medicated
Gold Standard Diagnostics Influenza B IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3010
In Commercial Distribution

  • B350GSD0130100 ()
GSD01-3010

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A IgG ELISA Test Kit
Gold Standard Diagnostics Corporation
GSD01-3009
In Commercial Distribution

  • B350GSD0130090 ()
GSD01-3009

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Wallac Oy
B064-112
Not in Commercial Distribution

  • 06438147344420 ()
B064-112

  • Inhibin A IVD, kit, fluorescent immunoassay
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
Wallac Oy
B064-112-P2
Not in Commercial Distribution

  • 06438147344406 ()
B064-112-P2

  • Inhibin A IVD, kit, fluorescent immunoassay
No Description
BIOCARE MEDICAL LLC
NPAI010T40
In Commercial Distribution

  • 00847627037718 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM171A
In Commercial Distribution

  • 00847627006707 ()


  • Inhibin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010C
In Commercial Distribution

  • 00847627005519 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010B
In Commercial Distribution

  • 00847627005502 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
CM010A
In Commercial Distribution

  • 00847627005496 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
OPAI010T60
In Commercial Distribution

  • 00847627025173 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
AVI010G
In Commercial Distribution

  • 00847627024190 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
PM010AA
In Commercial Distribution

  • 00847627010636 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
No Description
BIOCARE MEDICAL LLC
IP010G10
In Commercial Distribution

  • 00847627008459 ()


  • Chromogranin A IVD, kit, enzyme immunohistochemistry
Lipoprotein A (LP(a)) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097627
In Commercial Distribution

  • 00630414595559 ()
11097627

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
LK098.S
Not in Commercial Distribution

  • 05051700016841 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446069
In Commercial Distribution

  • 00842768007552 ()
  • 00842768019067 ()
OQHL11

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
FLEX Polyclonal Rabbit Anti-Human IgA Ready-to-Use (Dako Omnis)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GA510
In Commercial Distribution

  • 05700572034094 ()

  • Total Volume: 12 Milliliter


  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
anti-IgA Rabbit Monoclonal Antibody [EP170], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8381-C010
In Commercial Distribution

  • 00615233001931 ()
8381-C010

  • Immunoglobulin A antibody (anti-IgA) IVD, reagent
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