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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Validate ISX Multiple-type clinical chemistry analyte IVD, control
Lgc Clinical Diagnostics, Inc.
608mm
In Commercial Distribution

  • 00850011135396 ()


  • Multiple human hormone IVD, control
Validate Body Fluids 3 is intended for quantitative determination of Calibration Verification/Linearity on Automated Instruments.
Lgc Clinical Diagnostics, Inc.
207ro
In Commercial Distribution

  • 00850011135389 ()
207ro

  • Cancer antigen 19-9 (CA19-9) IVD, control
  • Carcinoembryonic antigen (CEA) IVD, control
Validate Fertility 3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
505ro
In Commercial Distribution

  • 00850011135365 ()

  • 2 tests
505ro

  • Anti-Mullerian hormone (AMH) IVD, control
  • Sex hormone binding globulin (SHBG) IVD, control
Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
308vt
In Commercial Distribution

  • 00850011135235 ()

  • 2 tests
308vt

  • Ferritin IVD, control
  • Folate (vitamin B9) IVD, control
  • Vitamin B12 IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ro
In Commercial Distribution

  • 00850011135228 ()

  • 2 tests
401ro

  • Multiple cardiac marker IVD, control
Validate ACTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
302mm
In Commercial Distribution

  • 00850011135211 ()

  • 2 tests
302mm

  • Adrenocorticotropic hormone (ACTH) IVD, control
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5.
Lgc Clinical Diagnostics, Inc.
409ro
In Commercial Distribution

  • 00850011135204 ()

  • 2 tests
409ro

  • Multiple cardiac marker IVD, control
  • Homocysteine IVD, control
Validate Body Fluids 2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
206ro
In Commercial Distribution

  • 00850011135198 ()

  • 2 tests
206ro

  • Multiple-type clinical chemistry analyte profile IVD, control
  • Multiple clinical chemistry enzyme IVD, control
Validate THY is intended for the determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
901re
In Commercial Distribution

  • 00850011135181 ()

  • 2 tests
901re

  • Total cortisol IVD, control
  • Total thyroxine (TT4) IVD, control
  • Free thyroxine (FT4) IVD, control
  • Thyroid stimulating hormone (TSH) IVD, control
  • Total triiodothyronine (TT3) IVD, control
  • Free triiodothyronine (FT3) IVD, control
Validate THY is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
901bc
In Commercial Distribution

  • 00850011135174 ()

  • 2 tests
901bc

  • Total cortisol IVD, control
  • Total thyroxine (TT4) IVD, control
  • Free thyroxine (FT4) IVD, control
  • Thyroid stimulating hormone (TSH) IVD, control
  • Total triiodothyronine (TT3) IVD, control
  • Free triiodothyronine (FT3) IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705vt
In Commercial Distribution

  • 00850011135150 ()

  • 2 tests
705vt

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ro
In Commercial Distribution

  • 00850011135143 ()

  • 2 tests
705ro

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ri
In Commercial Distribution

  • 00850011135136 ()

  • 2 tests
705ri

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705db
In Commercial Distribution

  • 00850011135129 ()

  • 2 tests
705db

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705bcc
In Commercial Distribution

  • 00850011135112 ()

  • 2 tests
705bcc

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705au
In Commercial Distribution

  • 00850011135105 ()

  • 2 tests
705au

  • Multiple urine analyte IVD, control
Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
705ab
In Commercial Distribution

  • 00850011135358 ()

  • 2 tests
705ab

  • Multiple urine analyte IVD, control
Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
605sa
In Commercial Distribution

  • 00850011135327 ()

  • 2 tests
605sa

  • Glycated haemoglobin (HbA1c) IVD, control
Validate IL-6 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
509ro
In Commercial Distribution

  • 00850011135310 ()

  • 2 tests
509ro

  • Interleukin-6 (IL-6) IVD, control
Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments.
Lgc Clinical Diagnostics, Inc.
504ab
In Commercial Distribution

  • 00850011135303 ()

  • 2 tests
504ab

  • Progesterone IVD, control
  • Estradiol (oestradiol) (E2) IVD, control
  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
  • Alpha-fetoprotein (AFP) IVD, control
Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
502ab
In Commercial Distribution

  • 00850011135297 ()

  • 2 tests
502ab

  • Total testosterone IVD, control
  • Prolactin IVD, control
  • Luteinizing hormone (LH) IVD, control
  • Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) IVD, control
Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
405ab
In Commercial Distribution

  • 00850011135280 ()

  • 2 tests
405ab

  • Troponin T/Troponin I IVD, control
Validate Diabetes is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
204ro
In Commercial Distribution

  • 00850011135273 ()

  • 2 tests
204ro

  • Cystatin C IVD, control
  • Insulin IVD, control
  • Beta-hydroxybutyrate IVD, control
  • Fructosamine IVD, control
  • C-peptide IVD, control
Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
407ab
In Commercial Distribution

  • 00850011135266 ()

  • 2 tests
407ab

  • Cancer antigen 15-3 (CA15-3) IVD, control
  • Cancer antigen 125 (CA125) IVD, control
  • Carcinoembryonic antigen (CEA) IVD, control
  • Cancer antigen 19-9 (CA19-9) IVD, control
Validate PTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
303ro
In Commercial Distribution

  • 00850011135259 ()

  • 2 tests
303ro

  • Parathyroid hormone (PTH) IVD, control
Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
308ab
In Commercial Distribution

  • 00850011135242 ()

  • 2 tests
308ab

  • Ferritin IVD, control
  • Folate (vitamin B9) IVD, control
  • Vitamin B12 IVD, control
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)
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vials each of level 1 & 2.
STRECK, INC.
240411
In Commercial Distribution

  • 00844509002192 ()

  • Total Volume: 3.0 Milliliter
240411

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.
STRECK, INC.
240408
In Commercial Distribution

  • 00844509002185 ()

  • Total Volume: 3.0 Milliliter
240408

  • Erythrocyte sedimentation rate (ESR) IVD, control
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213465
In Commercial Distribution

  • 00844509001997 ()

  • Total Volume: 45 Milliliter
213465

  • Urine sediment IVD, control
Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213396
In Commercial Distribution

  • 00844509001966 ()

  • Total Volume: 120 Milliliter
213396

  • Urine sediment IVD, control
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
STRECK, INC.
218991
In Commercial Distribution

  • 00844509001935 ()

  • Total Volume: 120 Milliliter
218991

  • Urine sediment IVD, control
A positive/negative post-vasectomy sperm count control. Contains 1 vial each of positive & negative control.
STRECK, INC.
230200
In Commercial Distribution

  • 00844509001898 ()

  • Total Volume: 300 Microliter
230200

  • Sperm concentration indicator IVD, control
A sperm count control containing stabilized sperm. Contains 1 vial each of level 1 & 2.
STRECK, INC.
230202
In Commercial Distribution

  • 00844509001867 ()

  • Total Volume: 300 Microliter
230202

  • Sperm concentration indicator IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 1 vial each of level 2 & 3.
STRECK, INC.
232758
In Commercial Distribution

  • 00844509001737 ()

  • Total Volume: 2.5 Milliliter
232758

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 3 vials each of level 1 & 3.
STRECK, INC.
232757
In Commercial Distribution

  • 00844509001720 ()

  • Total Volume: 2.5 Milliliter
232757

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 2 vials each of level 1, 2 & 3.
STRECK, INC.
232756
In Commercial Distribution

  • 00844509001713 ()

  • Total Volume: 2.5 Milliliter
232756

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 1 vial each of level 1, 2 & 3.
STRECK, INC.
232749
In Commercial Distribution

  • 00844509001706 ()

  • Total Volume: 2.5 Milliliter
232749

  • Glucose/haemoglobin (Hb) IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-4.
STRECK, INC.
291722
In Commercial Distribution

  • 00844509001669 ()

  • Total Volume: 3.0 Milliliter
291722

  • Full blood count IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.
STRECK, INC.
214112
In Commercial Distribution

  • 00844509001652 ()

  • Total Volume: 9.0 Milliliter
214112

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials each of level 1 & 2.
STRECK, INC.
214108
In Commercial Distribution

  • 00844509001645 ()

  • Total Volume: 9.0 Milliliter
214108

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vials each of level 1 & 2.
STRECK, INC.
214104
In Commercial Distribution

  • 00844509001638 ()

  • Total Volume: 9.0 Milliliter
214104

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 1 vial each of level 1 & 2.
STRECK, INC.
214102
In Commercial Distribution

  • 00844509001621 ()

  • Total Volume: 9.0 Milliliter
214102

  • Erythrocyte sedimentation rate (ESR) IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
STRECK, INC.
291720
In Commercial Distribution

  • 00844509001591 ()

  • Total Volume: 3.0 Milliliter
291720

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-5.
STRECK, INC.
291719
In Commercial Distribution

  • 00844509001584 ()

  • Total Volume: 3.0 Milliliter
291719

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-6.
STRECK, INC.
291718
In Commercial Distribution

  • 00844509001577 ()

  • Total Volume: 3.0 Milliliter
291718

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.
STRECK, INC.
291715
In Commercial Distribution

  • 00844509001560 ()

  • Total Volume: 3.0 Milliliter
291715

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
STRECK, INC.
291714
In Commercial Distribution

  • 00844509001447 ()

  • Total Volume: 3.0 Milliliter
291714

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-7.
STRECK, INC.
291713
In Commercial Distribution

  • 00844509001430 ()

  • Total Volume: 3.0 Milliliter
291713

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-7, PLT L1-6
STRECK, INC.
291712
In Commercial Distribution

  • 00844509001423 ()

  • Total Volume: 3.0 Milliliter
291712

  • Full blood count IVD, control
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