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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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Chang Medium D - 00893727002477

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
T105-100mL
In Commercial Distribution

  • 00893727002477 ()

  • Total Volume: 100 Milliliter
T105

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

CHANG Medium® D with Antibiotics - 00893727002439

CHANG Medium® D with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99404-100mL
In Commercial Distribution

  • 00893727002439 ()

  • Total Volume: 100 Milliliter
99404

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium MF with Gentamicin - 00893727002408

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-100ML
In Commercial Distribution

  • 00893727002408 ()

  • Total Volume: 100 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium BMC with Gentamicin - 00893727002392

Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-100ML
In Commercial Distribution

  • 00893727002392 ()

  • Total Volume: 100 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002217

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-20X5mL
In Commercial Distribution

  • 00893727002217 ()
  • 10893727002214 ()

  • Total Volume: 5 Milliliter
90128

  • IVF medium

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002200

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium

SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE - D77819960101

Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-6010
In Commercial Distribution

  • D77819960101 ()

  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
199-6010

  • Dental composite resin

CELL-DYN - 00380740017149

CELL-DYN RETIC PLUS CONTROL
ABBOTT LABORATORIES
08H62-01
In Commercial Distribution

  • 00380740017149 ()
08H6201

  • Reticulocyte count IVD, control

CELL-DYN - 00380740017118

CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-02
In Commercial Distribution

  • 00380740017118 ()
08H5902

  • Full blood count IVD, control

CELL-DYN - 00380740017101

CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-01
In Commercial Distribution

  • 00380740017101 ()
08H5901

  • Full blood count IVD, control

CELL-DYN - 00380740017095

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control

CELL-DYN - 00380740017088

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control

CELL-DYN - 00380740017071

CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator

ARCHITECT - 00380740156060

ARCHITECT SHBG Controls
Abbott GmbH
08K2611
In Commercial Distribution

  • 00380740156060 ()
08K2611

  • Sex hormone binding globulin (SHBG) IVD, control

ARCHITECT - 00380740156053

ARCHITECT SHBG Calibrators
Abbott GmbH
08K2602
In Commercial Distribution

  • 00380740156053 ()
08K2602

  • Sex hormone binding globulin (SHBG) IVD, calibrator

Alinity - 00380740151294

ALINITY h-series HemCal
Abbott GmbH
04U7302
In Commercial Distribution

  • 00380740151294 ()
04U7302

  • Full blood count IVD, calibrator

Alinity - 00380740151287

ALINITY h-series CONTROL 29P
Abbott GmbH
04U7212
In Commercial Distribution

  • 00380740151287 ()
04U7212

  • Full blood count IVD, control

Alinity - 00380740151270

ALINITY h-series CONTROL 29P
Abbott GmbH
04U7206
In Commercial Distribution

  • 00380740151270 ()
04U7206

  • Full blood count IVD, control

ARCHITECT - 00380740138912

ARCHITECT B.R.A.H.M.S PCT Controls
Abbott GmbH
06P2210
In Commercial Distribution

  • 00380740138912 ()
06P2210

  • Procalcitonin (PCT) IVD, calibrator

ARCHITECT - 00380740138905

ARCHITECT B.R.A.H.M.S PCT Calibrators
Abbott GmbH
06P2201
In Commercial Distribution

  • 00380740138905 ()
06P2201

  • Procalcitonin (PCT) IVD, calibrator

Alinity - 00380740136895

Alinity s Optics Verifier Kit
Abbott Ireland Diagnostics
01R3565
In Commercial Distribution

  • 00380740136895 ()
01R3565

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

CELL-DYN - 00380740119843

CELL-DYN 22 Plus Calibrator
ABBOTT LABORATORIES
09H73-01
In Commercial Distribution

  • 00380740119843 ()
09H7301

  • Full blood count IVD, calibrator

CELL-DYN - 00380740119836

CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-02
In Commercial Distribution

  • 00380740119836 ()
09H7202

  • Full blood count IVD, control

CELL-DYN - 00380740119829

CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-01
In Commercial Distribution

  • 00380740119829 ()
09H7201

  • Full blood count IVD, control

CELL-DYN - 00380740020347

CELL-DYN 18 PLUS CALIBRATOR
ABBOTT LABORATORIES
09H70-01
In Commercial Distribution

  • 00380740020347 ()
09H7001

  • Full blood count IVD, calibrator

CELL-DYN - 00380740020330

CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-02
In Commercial Distribution

  • 00380740020330 ()
09H6902

  • Full blood count IVD, control

CELL-DYN - 00380740020323

CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-01
In Commercial Distribution

  • 00380740020323 ()
09H6901

  • Full blood count IVD, control

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
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