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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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LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 1 (LIQ CHEM ASY PREMIUM PL - 05055273209006

This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAL4213
In Commercial Distribution

  • 05055273209006 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL - 05055273208986

This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy.
RANDOX LABORATORIES LIMITED
LAE4215
In Commercial Distribution

  • 05055273208986 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

LIQUID IMMUNOASSAY PREMIUM - TRI-LEVEL (LIQ IA PREMIUM 1, 2 AND 3) - 05055273207248

The Randox Liquid Immunoassay Premium - Tri-Level are liquid controls developed for use in the quality control of quantitative assays stated in this package insert.
RANDOX LABORATORIES LIMITED
LIA3108
In Commercial Distribution

  • 05055273207248 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

ARCHITECT - 00380740156039

ARCHITECT Intact PTH Calibrators
Abbott GmbH
08K2504
In Commercial Distribution

  • 00380740156039 ()
08K2504

  • Parathyroid hormone (PTH) IVD, calibrator

ARCHITECT - 00380740156022

ARCHITECT Intact PTH Controls
Abbott GmbH
08K2513
In Commercial Distribution

  • 00380740156022 ()
08K2513

  • Parathyroid hormone (PTH) IVD, control

ARCHITECT - 00380740175474

ARCHITECT STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
02R9801
In Commercial Distribution

  • 00380740175474 ()
02R9801

  • Troponin I IVD, calibrator

Alinity - 00380740155377

Alinity I Intact PTH Controls
Abbott GmbH
08P3111
In Commercial Distribution

  • 00380740155377 ()
08P3111

  • Parathyroid hormone (PTH) IVD, control

Alinity - 00380740155360

Alinity I Intact PTH Calibrators
Abbott GmbH
08P3102
In Commercial Distribution

  • 00380740155360 ()
08P3102

  • Parathyroid hormone (PTH) IVD, calibrator

IMMULITE® 2000 TSI CVM - 00630414006680

IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

IMMULITE Systems Total Testosterone CVM - 00630414979465

Testosterone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388170
In Commercial Distribution

  • 00630414979465 ()
LTWCVM

  • Total testosterone IVD, control

IMMULITE® Systems DHS Calibration Verification Material DHEA-SO4 - 00630414979373

HCG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387935
In Commercial Distribution

  • 00630414979373 ()
LDSCVM

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

IMMULITE® Systems ACT ACTH Calibration Verification Material - 00630414979366

ACTH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387863
In Commercial Distribution

  • 00630414979366 ()
LACCVM

  • Adrenocorticotropic hormone (ACTH) IVD, control

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

Kallestad - 00847865001724

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26115
In Commercial Distribution

  • 00847865001724 ()

  • 8 Well
  • 160 Tests
26115

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001717

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26112
In Commercial Distribution

  • 00847865001717 ()

  • 8 Well
  • 800 Tests
26112

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001700

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26111
In Commercial Distribution

  • 00847865001700 ()

  • 48 Tests
  • 8 Well
26111

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001571

Kallestad Crithidia luciliae 8 Well Slides
Bio-RAD Laboratories, Inc.
26110
In Commercial Distribution

  • 00847865001571 ()

  • 160 Tests
  • 8 Wells
26110

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001564

Kallestad Crithidia luciliae 8 Well Slides
Bio-RAD Laboratories, Inc.
26109
In Commercial Distribution

  • 00847865001564 ()

  • 48 Tests
  • 8 Wells
26109

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001557

Kallestad Crithidia luciliae 4 Well Slides
Bio-RAD Laboratories, Inc.
26108
In Commercial Distribution

  • 00847865001557 ()

  • 4 Wells
  • 80 Tests
26108

  • Native DNA antibody (anti-nDNA) IVD, reagent

Kallestad - 00847865001540

Kallestad Crithidia luciliae 4 Well Slides
Bio-RAD Laboratories, Inc.
26107
In Commercial Distribution

  • 00847865001540 ()

  • 4 Wells
  • 24 Tests
26107

  • Native DNA antibody (anti-nDNA) IVD, reagent

Liquichek - 00847661005827

Liquichek Whole Blood Immunosuppressant Control MiniPak (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
12000408
In Commercial Distribution

  • 00847661005827 ()
12000408

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

Liquichek - 00847661005810

Liquichek Whole Blood Immunosuppressant Control Level 4 (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
12000407
In Commercial Distribution

  • 00847661005810 ()
12000407

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

Liquichek - 00847661005803

Liquichek Whole Blood Immunosuppressant Control Level 3 (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
12000406
In Commercial Distribution

  • 00847661005803 ()
12000406

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

Liquichek - 00847661005797

Liquichek Whole Blood Immunosuppressant Control Level 2 (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
12000405
In Commercial Distribution

  • 00847661005797 ()
12000405

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

Liquichek - 00847661005766

Liquichek Whole Blood Immunosuppressant Control Level 1 (A human whole blood assayed control.)
BIO-RAD LABORATORIES, INC.
12000404
In Commercial Distribution

  • 00847661005766 ()
12000404

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control

Liquichek - 00847661005193

Liquichek Immunoassay Premium Control Trilevel MiniPak (A processed human serum assayed immunoassay Control.)
BIO-RAD LABORATORIES, INC.
27110X
In Commercial Distribution

  • 00847661005193 ()
27110X

  • Multiple clinical chemistry protein IVD, control

Liquichek - 00847661005186

Liquichek Immunoassay Premium Control Level 3 (A processed human serum assayed immunoassay Control.)
BIO-RAD LABORATORIES, INC.
27113
In Commercial Distribution

  • 00847661005186 ()
27113

  • Multiple clinical chemistry protein IVD, control

Liquichek - 00847661005179

Liquichek Immunoassay Premium Control Level 2 (A processed human serum assayed immunoassay Control.)
BIO-RAD LABORATORIES, INC.
27112
In Commercial Distribution

  • 00847661005179 ()
27112

  • Multiple clinical chemistry protein IVD, control

Liquichek - 00847661005162

Liquichek Immunoassay Premium Control Level 1 (A processed human serum assayed immunoassay Control.)
BIO-RAD LABORATORIES, INC.
27111
In Commercial Distribution

  • 00847661005162 ()
27111

  • Multiple clinical chemistry protein IVD, control

Liquichek - 00847661005155

Liquichek Immunoassay Premium Control Trilevel (A processed human serum assayed immunoassay Control.)
BIO-RAD LABORATORIES, INC.
27110
In Commercial Distribution

  • 00847661005155 ()
27110

  • Multiple clinical chemistry protein IVD, control

Multiqual - 00847661005148

Liquid Assayed Multiqual Trilevel MiniPak (A human serum assayed chemistry control.)
BIO-RAD LABORATORIES, INC.
338X
In Commercial Distribution

  • 00847661005148 ()
338X

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005131

Liquid Assayed Multiqual Level 3 (A human serum assayed chemistry control.)
BIO-RAD LABORATORIES, INC.
339
In Commercial Distribution

  • 00847661005131 ()
339

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005124

Liquid Assayed Multiqual Level 2 (A human serum assayed chemistry control.)
BIO-RAD LABORATORIES, INC.
338
In Commercial Distribution

  • 00847661005124 ()
338

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005117

Liquid Assayed Multiqual Level 1 (A human serum assayed chemistry control.)
BIO-RAD LABORATORIES, INC.
337
In Commercial Distribution

  • 00847661005117 ()
337

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005032

Liquid Assayed Multiqual Premium Trilevel MiniPak (A human serum assayed chemistry and protein control.)
BIO-RAD LABORATORIES, INC.
285X
In Commercial Distribution

  • 00847661005032 ()
285X

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005025

Liquid Assayed Multiqual Premium Level 3 (A human serum assayed chemistry and protein control.)
BIO-RAD LABORATORIES, INC.
286
In Commercial Distribution

  • 00847661005025 ()
286

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005018

Liquid Assayed Multiqual Premium Level 2 (A human serum assayed chemistry and protein control.)
BIO-RAD LABORATORIES, INC.
285
In Commercial Distribution

  • 00847661005018 ()
285

  • Multiple-type clinical chemistry analyte profile IVD, control

Multiqual - 00847661005001

Liquid Assayed Multiqual Premium Level 1 (A human serum assayed chemistry and protein control.)
BIO-RAD LABORATORIES, INC.
284
In Commercial Distribution

  • 00847661005001 ()
284

  • Multiple-type clinical chemistry analyte profile IVD, control

Liquichek - 00847661004844

Liquichek Urine Toxicology Control Level S2O Low Opiate MiniPak (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
706X
In Commercial Distribution

  • 00847661004844 ()
706X

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004837

Liquichek Urine Toxicology Control Level S2O Low Opiate (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
706
In Commercial Distribution

  • 00847661004837 ()
706

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004820

Liquichek Urine Toxicology Control Level S2O MiniPak (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
676X
In Commercial Distribution

  • 00847661004820 ()
676X

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004813

Liquichek Urine Toxicology Control Level S2O (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
676
In Commercial Distribution

  • 00847661004813 ()
676

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004806

Liquichek Urine Toxicology Control Level S1O MiniPak (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
673X
In Commercial Distribution

  • 00847661004806 ()
673X

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004790

Liquichek Urine Toxicology Control Level S1O (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
673
In Commercial Distribution

  • 00847661004790 ()
673

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004691

Liquichek Urine Toxicology Control Level S1O Low Opiate MiniPak (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
683X
In Commercial Distribution

  • 00847661004691 ()
683X

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004677

Liquichek Urine Toxicology Control Level S1O Low Opiate (A human urine drugs of abuse control.)
BIO-RAD LABORATORIES, INC.
683
In Commercial Distribution

  • 00847661004677 ()
683

  • Multiple therapeutic drugs/drugs of abuse IVD, control

Liquichek - 00847661004639

Liquichek Homocysteine Control MiniPak (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
288X
In Commercial Distribution

  • 00847661004639 ()
288X

  • Homocysteine IVD, control

Liquichek - 00847661004622

Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
289
In Commercial Distribution

  • 00847661004622 ()
289

  • Homocysteine IVD, control

Liquichek - 00847661004615

Liquichek Homocysteine Control Level 2 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
288
In Commercial Distribution

  • 00847661004615 ()
288

  • Homocysteine IVD, control

Liquichek - 00847661004608

Liquichek Homocysteine Control Level 1 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
287
In Commercial Distribution

  • 00847661004608 ()
287

  • Homocysteine IVD, control
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