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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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Tokuyama Shield Force Plus - 04548190151417

Mini-kit
TOKUYAMA DENTAL CORPORATION
15141
In Commercial Distribution

  • 04548190151417 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing

Tokuyama Shield Force Plus - 04548190151219

Refill
TOKUYAMA DENTAL CORPORATION
15121
In Commercial Distribution

  • 04548190151219 ()


  • Dental coating, tooth-desensitizing
  • Dental cavity varnish

Tokuyama Shield Force Plus - 04548190151110

Kit
TOKUYAMA DENTAL CORPORATION
15111
In Commercial Distribution

  • 04548190151110 ()


  • Dental cavity varnish
  • Dental coating, tooth-desensitizing

Tokuyama Bond Force - 04548190149926

MIni kit
TOKUYAMA DENTAL CORPORATION
14992
In Commercial Distribution

  • 04548190149926 ()


  • Dentine adhesive

Tokuyama Bond Force - 04548190149421

Pen, Twin Pen
TOKUYAMA DENTAL CORPORATION
14942
In Commercial Distribution

  • 04548190149421 ()
  • 94548190149370 ()


  • Dentine adhesive

Tokuyama Bond Force - 04548190149322

Refill
TOKUYAMA DENTAL CORPORATION
14932
In Commercial Distribution

  • 04548190149322 ()


  • Dentine adhesive

One-UP Bond F Plus - 04548190147373

Bonding Agent B
TOKUYAMA DENTAL CORPORATION
14737
In Commercial Distribution

  • 04548190147373 ()


  • Dentine adhesive

One-UP Bond F Plus - 04548190147069

Kit
TOKUYAMA DENTAL CORPORATION
14706
In Commercial Distribution

  • 04548190147069 ()


  • Dentine adhesive

ESR-Chex Plus - 00844509002192

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

ESR-Chex Plus - 00844509002185

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

UA-Cellular for UF - 00844509001997

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

UA-Cellular for IQ - 00844509001966

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

UA-Cellular Complete - 00844509001935

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

Sperm-Chex Post VC - 00844509001898

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

Sperm-Chex - 00844509001867

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

HQ-Chex - 00844509001737

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

HQ-Chex - 00844509001720

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

HQ-Chex - 00844509001713

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

HQ-Chex - 00844509001706

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

CVA - 00844509001669

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

ESR-Chex - 00844509001652

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

ESR-Chex - 00844509001645

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

ESR-Chex - 00844509001638

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

ESR-Chex - 00844509001621

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

CVA for CellDyn - 00844509001591

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

CVA for CellDyn - 00844509001584

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

CVA for CellDyn - 00844509001577

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

CVA for CellDyn - 00844509001560

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

CVA - 00844509001447

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

CVA - 00844509001430

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

CVA - 00844509001423

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

CVA - 00844509001416

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 L1-5.
STRECK, INC.
291711
In Commercial Distribution

  • 00844509001416 ()

  • Total Volume: 3.0 Milliliter
291711

  • Full blood count IVD, control

CVA - 00844509001409

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 L1-5.
STRECK, INC.
291710
In Commercial Distribution

  • 00844509001409 ()

  • Total Volume: 3.0 Milliliter
291710

  • Full blood count IVD, control

CVA - 00844509001393

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.
291709
In Commercial Distribution

  • 00844509001393 ()

  • Total Volume: 3.0 Milliliter
291709

  • Full blood count IVD, control

CVA - 00844509001386

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.
291708
In Commercial Distribution

  • 00844509001386 ()

  • Total Volume: 3.0 Milliliter
291708

  • Full blood count IVD, control

CVA - 00844509001379

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.
STRECK, INC.
291504
In Commercial Distribution

  • 00844509001379 ()

  • Total Volume: 3.0 Milliliter
291504

  • Full blood count IVD, control

STaK-Chex - 00844509001188

A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials each of low, normal & high levels.
STRECK, INC.
225512
In Commercial Distribution

  • 00844509001188 ()

  • Total Volume: 4.0 Milliliter
225512

  • Full blood count IVD, control

STaK-Chex - 00844509001171

A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
225503
In Commercial Distribution

  • 00844509001171 ()

  • Total Volume: 4.0 Milliliter
225503

  • Full blood count IVD, control

Retic-Chex Linearity BC - 00844509001133

Retic-Chex Linearity BC is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285535
In Commercial Distribution

  • 00844509001133 ()

  • Total Volume: 3.0 Milliliter
285535

  • Reticulocyte count IVD, control

Retic-Chex Linearity - 00844509001072

Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285633
In Commercial Distribution

  • 00844509001072 ()

  • Total Volume: 2.5 Milliliter
285633

  • Reticulocyte count IVD, control

Retic-Chex Linearity - 00844509001065

Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285532
In Commercial Distribution

  • 00844509001065 ()

  • Total Volume: 2.5 Milliliter
285532

  • Reticulocyte count IVD, control

A1c-Cellular Linearity - 00844509001003

A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter.
STRECK, INC.
285536
In Commercial Distribution

  • 00844509001003 ()

  • Total Volume: 2.0 Milliliter
285536

  • Glycated haemoglobin (HbA1c) IVD, control

A1c-Cellular - 00844509000945

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control

A1c-Cellular - 00844509000938

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control

Sickle-Chex - 00844509000891

A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 2 each of P+ & N-
STRECK, INC.
217654
In Commercial Distribution

  • 00844509000891 ()

  • Total Volume: 2.5 Milliliter
217654

  • Haemoglobin S (HbS) IVD, control

Sickle-Chex - 00844509000884

A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 1 each of P+ & N-
STRECK, INC.
217653
In Commercial Distribution

  • 00844509000884 ()

  • Total Volume: 2.5 Milliliter
217653

  • Haemoglobin S (HbS) IVD, control

Para 4 - 00844509000815

A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of normal & high levels.
STRECK, INC.
215428
In Commercial Distribution

  • 00844509000815 ()

  • Total Volume: 1.5 Milliliter
215428

  • Full blood count IVD, control

Para 4 - 00844509000808

A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials each of low, normal & high levels.
STRECK, INC.
215418
In Commercial Distribution

  • 00844509000808 ()

  • Total Volume: 1.5 Milliliter
215418

  • Full blood count IVD, control

Para 4 - 00844509000792

A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of low, normal & high levels.
STRECK, INC.
215412
In Commercial Distribution

  • 00844509000792 ()

  • Total Volume: 1.5 Milliliter
215412

  • Full blood count IVD, control

Para 4 - 00844509000785

A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of low & high levels.
STRECK, INC.
215409
In Commercial Distribution

  • 00844509000785 ()

  • Total Volume: 1.5 Milliliter
215409

  • Full blood count IVD, control
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