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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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Liquichek - 00847661000624

Liquichek Cardiac Markers Plus Control Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
181
In Commercial Distribution

  • 00847661000624 ()
181

  • Multiple cardiac marker IVD, control

Liquichek - 00847661000617

Liquichek Cardiac Markers Plus Control Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
180
In Commercial Distribution

  • 00847661000617 ()
180

  • Multiple cardiac marker IVD, control

Liquichek - 00847661000518

Liquichek ToRCH Plus IgM Control, Negative MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230NX
In Commercial Distribution

  • 00847661000518 ()
230NX

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000501

Liquichek ToRCH Plus IgM Control, Positive MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229PX
In Commercial Distribution

  • 00847661000501 ()
229PX

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000273

Liquichek ToRCH Plus IgM Control, Negative (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230
In Commercial Distribution

  • 00847661000273 ()
230

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000266

Liquichek ToRCH Plus IgM Control, Positive (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229
In Commercial Distribution

  • 00847661000266 ()
229

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000037

Liquichek Pediatric Control Level 2 (An assayed pediatric control.)
BIO-RAD LABORATORIES, INC.
355
In Commercial Distribution

  • 00847661000037 ()
355

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 00847661000020

Liquichek Pediatric Control Level 1 (An assayed pediatric control.)
BIO-RAD LABORATORIES, INC.
354
In Commercial Distribution

  • 00847661000020 ()
354

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 00847661000013

Liquichek Unassayed Chemistry Control (Human) Level 2 (A human serum unassayed chemistry control.)
BIO-RAD LABORATORIES, INC.
692
In Commercial Distribution

  • 00847661000013 ()
692

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 00847661000006

Liquichek Unassayed Chemistry Control (Human) Level 1 (A human serum unassayed chemistry control.)
BIO-RAD LABORATORIES, INC.
691
In Commercial Distribution

  • 00847661000006 ()
691

  • Multiple-type clinical chemistry analyte profile IVD, control

Low-Tox-H Rabbit Complement - 00628451099208

Low-Tox®-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3335
In Commercial Distribution


  • Total Volume: 10 Milliliter
CL3335

  • Complement reagent IVD

Low-Tox-H Rabbit Complement - 00628451099192

Low-Tox-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3331
In Commercial Distribution


  • Total Volume: 10 Milliliter
CL3331

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099161

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3120
In Commercial Distribution


  • Total Volume: 100 Milliliter
CL3120

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099154

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3115
In Commercial Distribution


  • Total Volume: 25 Milliliter
CL3115

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099147

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3113
In Commercial Distribution


  • Total Volume: 3 Milliliter
CL3113

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099130

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3112
In Commercial Distribution


  • Total Volume: 20 Milliliter
CL3112

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099123

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3111
In Commercial Distribution


  • Total Volume: 25 Milliliter
CL3111

  • Complement reagent IVD

CD68 [KP1] BSA Free (1.0mg/ml) - 00847627031556

No Description
BIOCARE MEDICAL LLC
ACC033CFW
In Commercial Distribution

  • 00847627031556 ()


  • CD68 cell marker IVD, antibody

CD3 [BC33] BSA Free (1.0mg/ml) - 00847627024718

Alternate name : CD3 [BC33]
BIOCARE MEDICAL LLC
ACC3170CFW
In Commercial Distribution

  • 00847627024718 ()


  • CD3 cell marker IVD, antibody

CD8 [C8/144B] BSA Free (1.0mg/ml) - 00847627024701

Alternate name : CD8 [C8/144B]
BIOCARE MEDICAL LLC
ACC3160CFW
In Commercial Distribution

  • 00847627024701 ()


  • CD8 cell marker IVD, antibody

CD45RO [UCHL-1] BSA Free (1.0mg/ml) - 00847627024695

Alternate name : CD45RO [UCHL-1]
BIOCARE MEDICAL LLC
ACC006CFW
In Commercial Distribution

  • 00847627024695 ()


  • CD45RO cell marker IVD, antibody

SOX10 [BC34] BSA Free (1.0mg/ml) - 00847627024688

No Description
BIOCARE MEDICAL LLC
ACC3099CFW
In Commercial Distribution

  • 00847627024688 ()


  • SOXE protein IVD, antibody

p40 [BC28] BSA Free (1.0mg/ml) - 00847627024619

No Description
BIOCARE MEDICAL LLC
ACC3066CF
In Commercial Distribution

  • 00847627024619 ()


  • p40 protein IVD, antibody

p40 [BC28] BSA Free (1.0mg/ml) - 00847627024404

No Description
BIOCARE MEDICAL LLC
ACC3066CFW
In Commercial Distribution

  • 00847627024404 ()


  • p40 protein IVD, antibody

CD3 [BC33] BSA Free (1.0mg/ml) - 00847627014825

Alternate name : CD3 [BC33]
BIOCARE MEDICAL LLC
ACC3170CF
In Commercial Distribution

  • 00847627014825 ()


  • CD3 cell marker IVD, antibody

CD8 [C8/144B] BSA Free (1.0mg/ml) - 00847627014818

Alternate name : CD8 [C8/144B]
BIOCARE MEDICAL LLC
ACC3160CF
In Commercial Distribution

  • 00847627014818 ()


  • CD8 cell marker IVD, antibody

SOX10 [BC34] BSA Free (1.0mg/ml) - 00847627014801

No Description
BIOCARE MEDICAL LLC
ACC3099CF
In Commercial Distribution

  • 00847627014801 ()


  • SOXE protein IVD, antibody

CD68 [KP1] BSA Free (1.0mg/ml) - 00847627014795

Alternate name : CD68 [KP1]
BIOCARE MEDICAL LLC
ACC033CF
In Commercial Distribution

  • 00847627014795 ()


  • CD68 cell marker IVD, antibody

CD45RO [UCHL-1] BSA Free (1.0mg/ml) - 00847627014788

Alternate name : CD45RO [UCHL-1]
BIOCARE MEDICAL LLC
ACC006CF
In Commercial Distribution

  • 00847627014788 ()


  • CD45RO cell marker IVD, antibody

IMMULITE® 3RD GEN. PSA CVM - 00630414601939

3rd Generation PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713725
In Commercial Distribution

  • 00630414601939 ()
L3PSCVM

  • Total prostate specific antigen (tPSA) IVD, control

ADVIA Centaur® iPTH Calibrator - 00630414587486

PTH intact - CENTAUR - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

IMMULITE® Systems COR Calibration Verification Material Cortisol - 00630414977485

Cortisol Sample Diluent CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487396
In Commercial Distribution

  • 00630414977485 ()
LCOCVM

  • Total cortisol IVD, control

IMMULITE® Systems VB Calibration Verification Material Vitamin B12 - 00630414971421

Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control

IMMULITE® TOXOPLASMA QUANT. CVM - 00630414971414

Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems TBG Calibration Verification Material TBG - 00630414971377

TBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373705
In Commercial Distribution

  • 00630414971377 ()
LTBCVM

  • Thyroxine binding globulin (TBG) IVD, control

IMMULITE® Systems T3 Calibration Verification Material Total T3 - 00630414971360

Total T3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373704
In Commercial Distribution

  • 00630414971360 ()
LT3CVM

  • Total triiodothyronine (TT3) IVD, control

IMMULITE® Systems fPS Calibration Verification Material Free PSA - 00630414971346

Free PSA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373702
In Commercial Distribution

  • 00630414971346 ()
LPFCVM

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D - 00630414971322

Pyrilinks-D CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373700
In Commercial Distribution

  • 00630414971322 ()
LPDCVM

  • Cyclic adenosine monophosphate (cAMP) IVD, control

IMMULITE® Systems MYO Calibration Verification Material Myoglobin - 00630414971292

Myoglobin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373696
In Commercial Distribution

  • 00630414971292 ()
LMYCVM

  • Myoglobin IVD, control
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