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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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Fort Worth Diagnostics - 00850051429066

Candida auris Primer Set
Fort Worth Diagnostics, LLC
CAUR002
In Commercial Distribution

  • 00850051429066 ()
CAUR002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429059

Candida auris Primer Set
Fort Worth Diagnostics, LLC
CAUR001
In Commercial Distribution

  • 00850051429059 ()
CAUR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429042

Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR001
In Commercial Distribution

  • 00850051429042 ()
EHR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429035

Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR001
In Commercial Distribution

  • 00850051429035 ()
BOR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429028

Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA001
In Commercial Distribution

  • 00850051429028 ()
ANA001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429004

Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB001
In Commercial Distribution

  • 00850051429004 ()
BAB001

  • Assay development analyte-specific reagent IVD

Low-Tox-H Rabbit Complement - 06284510990202

Low-Tox®-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3335
Not in Commercial Distribution

  • 06284510990202 ()

  • Total Volume: 10 Milliliter
CL3335

  • Complement reagent IVD

Low-Tox-H Rabbit Complement - 06284510990196

Low-Tox-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3331
Not in Commercial Distribution

  • 06284510990196 ()

  • Total Volume: 10 Milliliter
CL3331

  • Complement reagent IVD

Standard Rabbit Complement - 06284510990165

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3120
Not in Commercial Distribution

  • 06284510990165 ()

  • Total Volume: 100 Milliliter
CL3120

  • Complement reagent IVD

Standard Rabbit Complement - 06284510990158

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3115
Not in Commercial Distribution

  • 06284510990158 ()

  • Total Volume: 25 Milliliter
CL3115

  • Complement reagent IVD

Standard Rabbit Complement - 06284510990141

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3113
Not in Commercial Distribution

  • 06284510990141 ()

  • Total Volume: 3 Milliliter
CL3113

  • Complement reagent IVD

Standard Rabbit Complement - 06284510990134

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3112
Not in Commercial Distribution

  • 06284510990134 ()

  • Total Volume: 20 Milliliter
CL3112

  • Complement reagent IVD

Standard Rabbit Complement - 06284510990127

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3111
Not in Commercial Distribution

  • 06284510990127 ()

  • Total Volume: 25 Milliliter
CL3111

  • Complement reagent IVD

InteliQ - 03610522354665

InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019558
In Commercial Distribution

  • 03610522354665 ()
12019558

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522354658

Liquichek Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019576
In Commercial Distribution

  • 03610522354658 ()
12019576

  • Multiple clinical chemistry protein IVD, control

Exact Diagnostics - 03610522350773

Bulk CSF Negative
EXACT DIAGNOSTICS, LLC
12019432
In Commercial Distribution

  • 03610522350773 ()
12019432

  • PCR/NAT negative control IVD

InteliQ - 03610522248902

InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248896

InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248889

InteliQ Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016485
In Commercial Distribution

  • 03610522248889 ()
12016485

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248872

InteliQ Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016484
In Commercial Distribution

  • 03610522248872 ()
12016484

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248698

Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016475
In Commercial Distribution

  • 03610522248698 ()
12016475

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248681

Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016474
In Commercial Distribution

  • 03610522248681 ()
12016474

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248674

Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016473
In Commercial Distribution

  • 03610522248674 ()
12016473

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248667

Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016472
In Commercial Distribution

  • 03610522248667 ()
12016472

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248407

Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016450
In Commercial Distribution

  • 03610522248407 ()
12016450

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248391

Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016449
In Commercial Distribution

  • 03610522248391 ()
12016449

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248384

Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016448
In Commercial Distribution

  • 03610522248384 ()

  • 6 x 3 ml
12016448

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248377

Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016447
In Commercial Distribution

  • 03610522248377 ()
12016447

  • Multiple cardiac marker IVD, control

InteliQ - 03610522231508

InteliQ Specialty Immunoassay Plus Control Trilevel MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015709
In Commercial Distribution

  • 03610522231508 ()
12015709

  • Multiple clinical chemistry protein IVD, control

InteliQ - 03610522231492

InteliQ Specialty Immunoassay Plus Control Level 3 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015708
In Commercial Distribution

  • 03610522231492 ()
12015708

  • Multiple clinical chemistry protein IVD, control

InteliQ - 03610522231485

InteliQ Specialty Immunoassay Plus Control Level 2 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015707
In Commercial Distribution

  • 03610522231485 ()
12015707

  • Multiple clinical chemistry protein IVD, control

InteliQ - 03610522231478

InteliQ Specialty Immunoassay Plus Control Level 1 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015706
In Commercial Distribution

  • 03610522231478 ()
12015706

  • Multiple clinical chemistry protein IVD, control

InteliQ - 03610522231461

InteliQ Specialty Immunoassay Plus Control Level Low (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015705
In Commercial Distribution

  • 03610522231461 ()
12015705

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522231119

Liquichek Specialty Immunoassay Plus Control Trilevel MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015648
In Commercial Distribution

  • 03610522231119 ()
12015648

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522231102

Liquichek Specialty Immunoassay Plus Control Level 3 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015647
In Commercial Distribution

  • 03610522231102 ()
12015647

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522231096

Liquichek Specialty Immunoassay Plus Control Level 2 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12015646
In Commercial Distribution

  • 03610522231096 ()
12015646

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522231072

Liquichek Specialty Immunoassay Plus Control Level Low (A human serum assayed immunoassay control,)
BIO-RAD LABORATORIES, INC.
12015644
In Commercial Distribution

  • 03610522231072 ()
12015644

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522142415

Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
12011331
In Commercial Distribution

  • 03610522142415 ()
12011331

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 03610522141975

Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
12011334
In Commercial Distribution

  • 03610522141975 ()
12011334

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 03610522141968

Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
12011245
In Commercial Distribution

  • 03610522141968 ()
12011345

  • Glycated haemoglobin (HbA1c) IVD, control
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