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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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Bone Marrow Culture Medium with Gentamicin. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91031-100ML
In Commercial Distribution

  • 00810195240569 ()
91031

  • Cell culture medium IVD
CHANG Medium MF with Gentamicin. Mitogen Free Medium for Culture of Hemopoietic Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91005-100ML
In Commercial Distribution

  • 00810195240545 ()
91005

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91004-500ML
In Commercial Distribution

  • 00810195240538 ()
91004

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91004-100ML
In Commercial Distribution

  • 00810195240521 ()
91004

  • Cell culture medium IVD
Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin
IRVINE SCIENTIFIC, LLC
90128-20x5ML
In Commercial Distribution

  • 00810195240163 ()
90128

  • IVF medium
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin
IRVINE SCIENTIFIC, LLC
90129-20x5ML
In Commercial Distribution

  • 00810195240156 ()
90129

  • IVF medium
FIT SA F03 A2 1G
SHOFU DENTAL CORPORATION
Y2571
In Commercial Distribution

  • E235Y25710 ()
Y2571

  • Dental composite resin
FIT SA F03 A1 1G
SHOFU DENTAL CORPORATION
Y2568
In Commercial Distribution

  • E235Y25680 ()
Y2568

  • Dental composite resin
FIT SA F10 A4 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25630 ()
Y2563

  • Dental composite resin
FIT SA F03B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25540 ()
Y2554

  • Dental composite resin
FIT SA F03A3 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25520 ()
Y2552

  • Dental composite resin
FIT SA F03A1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25500 ()
Y2550

  • Dental composite resin
BEAUTIFIL KIDS SA B1 1.0g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10150 ()
Y1015

  • Dental composite resin
BEAUTIFIL KIDS SA A2 1.0g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10140 ()
Y1014

  • Dental composite resin
BEAUTIFIL KIDS SA B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10120 ()
Y1012

  • Dental composite resin
BEAUTIFIL KIDS SA A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y10110 ()
Y1011

  • Dental composite resin
FIT SA F10 A2 1G
SHOFU DENTAL CORPORATION
Y2572
In Commercial Distribution

  • E235Y25720 ()
Y2572

  • Dental composite resin
FIT SA F10 A1 1G
SHOFU DENTAL CORPORATION
Y2569
In Commercial Distribution

  • E235Y25690 ()
Y2569

  • Dental composite resin
FIT SA F10 B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25640 ()
Y2564

  • Dental composite resin
FIT SA F10 A3 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25620 ()
Y2562

  • Dental composite resin
FIT SA F10 A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25610 ()
Y2561

  • Dental composite resin
FIT SA F10 A1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25600 ()
Y2560

  • Dental composite resin
FIT SA F03A4 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25530 ()
Y2553

  • Dental composite resin
FIT SA F03A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25510 ()
Y2551

  • Dental composite resin
CONTROL 550-13 CLOTTRAC HR 11L 30PK
MEDTRONIC, INC.
550-13
In Commercial Distribution

  • 20763000014876 ()
  • 00763000014872 ()


  • Multiple coagulation factor IVD, control
CONTROL 550-12 CLOTTRAC HTC 15BX
MEDTRONIC, INC.
550-12
In Commercial Distribution

  • 20763000014869 ()
  • 00763000014865 ()


  • Multiple coagulation factor IVD, control
CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
MEDTRONIC, INC.
550-10
In Commercial Distribution

  • 20763000014852 ()
  • 00763000014858 ()


  • Multiple coagulation factor IVD, control
CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-09
In Commercial Distribution

  • 20763000014845 ()
  • 00763000014841 ()


  • Multiple coagulation factor IVD, control
CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-08
In Commercial Distribution

  • 20763000014838 ()
  • 00763000014834 ()


  • Multiple coagulation factor IVD, control
CONTROL 550-07 CLOTTRAC HR 11L 15BX
MEDTRONIC, INC.
550-07
In Commercial Distribution

  • 20763000014821 ()
  • 00763000014827 ()


  • Multiple coagulation factor IVD, control
CONTROL 550-01 CLOTTRAC CWB 11L 15BX
MEDTRONIC, INC.
550-01
In Commercial Distribution

  • 20763000014814 ()
  • 00763000014810 ()


  • Multiple coagulation factor IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 3.
STRECK, INC.
232755
In Commercial Distribution

  • 20844509001694 ()

  • Total Volume: 2.5 Milliliter
232755

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 2.
STRECK, INC.
232754
In Commercial Distribution

  • 20844509001687 ()

  • Total Volume: 2.5 Milliliter
232754

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 1.
STRECK, INC.
232753
In Commercial Distribution

  • 20844509001670 ()

  • Total Volume: 2.5 Milliliter
232753

  • Glucose/haemoglobin (Hb) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 2.
STRECK, INC.
214024
In Commercial Distribution

  • 20844509001618 ()

  • Total Volume: 9.0 Milliliter
214024

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 1.
STRECK, INC.
214014
In Commercial Distribution

  • 20844509001601 ()

  • Total Volume: 9.0 Milliliter
214014

  • Erythrocyte sedimentation rate (ESR) IVD, control
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 of high level.
STRECK, INC.
225534
In Commercial Distribution

  • 20844509001168 ()

  • Total Volume: 4.0 Milliliter
225534

  • Full blood count IVD, control
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 12 vials of normal level.
STRECK, INC.
225114
In Commercial Distribution

  • 20844509001151 ()

  • Total Volume: 4.0 Milliliter
225114

  • Full blood count IVD, control
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 of low level.
STRECK, INC.
225524
In Commercial Distribution

  • 20844509001144 ()

  • Total Volume: 4.0 Milliliter
225524

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 3.
STRECK, INC.
200069
In Commercial Distribution

  • 20844509000574 ()

  • Total Volume: 3.0 Milliliter
200069

  • Full blood count IVD, control
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