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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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CD39 [EPR20627] - 00847627030580

No Description
BIOCARE MEDICAL LLC
AVI3283G
In Commercial Distribution

  • 00847627030580 ()


  • Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT)

Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges - 04987270231432

No Description
FUJIREBIO INC.
231432
In Commercial Distribution

  • 04987270231432 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges - 04987270231753

No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

N Latex ADNase B - 00842768013317

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

COBAS® AmpliScreen HCV Test, v2.0 - 00875197001068

No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197001068 ()
03302563018

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Elecsys Beta-Amyloid (1-42) CSF II - 07613336208359

No Description
Roche Diagnostics GmbH
08821909160
In Commercial Distribution

  • 07613336208359 ()
08821909160

  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110CB33120

No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System - B110CB33060

No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Elecsys beta-Amyloid (1-42) CSF II - 07613336166321

No Description
Roche Diagnostics GmbH
08821941190
In Commercial Distribution

  • 07613336166321 ()
08821941190

  • Amyloid B component IVD, kit, chemiluminescent immunoassay

cobas® MPX (96 tests) - 20875197004766

No Description
Roche Diagnostics GmbH
06998909190
In Commercial Distribution

  • 20875197004766 ()
06998909190

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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