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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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Retic-Chex II - 00844509000457

A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1 & 2.
STRECK, INC.
285212
In Commercial Distribution

  • 00844509000457 ()

  • Total Volume: 1.0 Milliliter
285212

  • Reticulocyte count IVD, control

Retic-Chex II - 00844509000440

A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1 & 3.
STRECK, INC.
285211
In Commercial Distribution

  • 00844509000440 ()

  • Total Volume: 1.0 Milliliter
285211

  • Reticulocyte count IVD, control

uTASWako DCP Calibrator Set - 00856626006212

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
Not in Commercial Distribution

  • 00856626006212 ()
999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

uTASWako AFP-L3 Calibrator Set - 00856626006168

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-60901
Not in Commercial Distribution

  • 00856626006168 ()
997-60901

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator

Autokit CH50 - 00856626006113

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
Not in Commercial Distribution

  • 00856626006113 ()
995-40801

  • Total complement activity (CH50) IVD, reagent

Validate - 00850011135808

Growth Hormone 2 Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
511ro
In Commercial Distribution

  • 00850011135808 ()


  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control

AccuTrak - 00850011135792

AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control

VALIDATE - 00850011135785

VALIDATE tTau CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
805re
In Commercial Distribution

  • 00850011135785 ()


  • Tau protein IVD, control

VALIDATE - 00850011135778

VALIDATE pTau181 CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
804re
In Commercial Distribution

  • 00850011135778 ()


  • Tau protein IVD, control

VALIDATE - 00850011135761

VALIDATE MTX Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
310ro
In Commercial Distribution

  • 00850011135761 ()


  • Methotrexate therapeutic drug monitoring IVD, control
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