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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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CELL-DYN - 00380740017095

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control

CELL-DYN - 00380740017088

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control

CELL-DYN - 00380740017071

CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator

OncoMate MSI Dx Analysis System - 00849811031717

Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)

VERSANT® Tissue Preparation Reagents (Box 3) - 00630414588810

VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD

Liquichek - 00847661004301

Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292X
In Commercial Distribution

  • 00847661004301 ()
292X

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 00847661004295

Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
293
In Commercial Distribution

  • 00847661004295 ()
293

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 00847661004288

Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292
In Commercial Distribution

  • 00847661004288 ()
292

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 00847661004271

Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
291
In Commercial Distribution

  • 00847661004271 ()
291

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 00847661002192

Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172X
In Commercial Distribution

  • 00847661002192 ()
172X

  • Glycated haemoglobin (HbA1c) IVD, control
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