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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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Licox® - 10381780041153

Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM2S
Not in Commercial Distribution

  • M273IM2S1 ()
  • 10381780041153 ()

  • 130 mm x 35 mm x 313 mm
IM2S

  • Intracerebral sensor catheter, short-term

Licox® - 10381780041146

Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM1S
Not in Commercial Distribution

  • M273IM1S1 ()
  • 10381780041146 ()

  • 130 mm x 35 mm x 313 mm
IM1S

  • Intracerebral sensor catheter, short-term

Licox® - 10381780041078

Licox® Combined Oxygen and Temperature Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1P1
Not in Commercial Distribution

  • M273CC1P11 ()
  • 10381780041078 ()

  • 130 mm x 35 mm x 313 mm
CC1P1

  • Intracerebral sensor catheter, short-term

Licox® - 10381780041061

Licox® Oxygen Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1SB
Not in Commercial Distribution

  • M273CC1SB1 ()
  • 10381780041061 ()

  • 130 mm x 35 mm x 313 mm
CC1SB

  • Intracerebral sensor catheter, short-term

DETECTABUSE - 00810042683921

SERIES V-H, Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19555252
In Commercial Distribution

  • 00810042683921 ()
19555252

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682658

ORAL-SKREEN, 3X Cutoff, 6x20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109-6pk
In Commercial Distribution

  • 00810042682658 ()
20200109-6pk

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682634

ORAL-SKREEN , Neg/3X POSITIVE KITBOX, 2x20mL
BIOCHEMICAL DIAGNOSTICS INC
702030
In Commercial Distribution

  • 00810042682634 ()
702030

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682627

Oral Fluid, 3X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200109
In Commercial Distribution

  • 00810042682627 ()
20200109

  • Multiple drugs of abuse IVD, control

SALIVABUSE - 00810042682597

Oral Fluid, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200103
In Commercial Distribution

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control

CLOTtrac™ - 20763000014876

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

  • 20763000014876 ()
  • 00763000014872 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014869

CONTROL 550-12 CLOTTRAC HTC 15BX
MEDTRONIC, INC.
550-12
In Commercial Distribution

  • 20763000014869 ()
  • 00763000014865 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014852

CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
MEDTRONIC, INC.
550-10
In Commercial Distribution

  • 20763000014852 ()
  • 00763000014858 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014845

CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-09
In Commercial Distribution

  • 20763000014845 ()
  • 00763000014841 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014838

CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-08
In Commercial Distribution

  • 20763000014838 ()
  • 00763000014834 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014821

CONTROL 550-07 CLOTTRAC HR 11L 15BX
MEDTRONIC, INC.
550-07
In Commercial Distribution

  • 20763000014821 ()
  • 00763000014827 ()


  • Multiple coagulation factor IVD, control

CLOTtrac™ - 20763000014814

CONTROL 550-01 CLOTTRAC CWB 11L 15BX
MEDTRONIC, INC.
550-01
In Commercial Distribution

  • 20763000014814 ()
  • 00763000014810 ()


  • Multiple coagulation factor IVD, control

HQ-Chex - 20844509001694

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

HQ-Chex - 20844509001687

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

HQ-Chex - 20844509001670

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

ESR-Chex - 20844509001618

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

ESR-Chex - 20844509001601

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

STaK-Chex - 20844509001168

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

STaK-Chex - 20844509001151

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

STaK-Chex - 20844509001144

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

Cell-Chex Auto - 20844509000574

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

Cell-Chex Auto - 20844509000567

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 2.
STRECK, INC.
200068
In Commercial Distribution

  • 20844509000567 ()

  • Total Volume: 3.0 Milliliter
200068

  • Full blood count IVD, control

Cell-Chex Auto - 20844509000550

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 1.
STRECK, INC.
200067
In Commercial Distribution

  • 20844509000550 ()

  • Total Volume: 3.0 Milliliter
200067

  • Full blood count IVD, control

CD-Chex Plus BC - 20844509000529

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213371
In Commercial Distribution

  • 20844509000529 ()

  • Total Volume: 3.0 Milliliter
213371

  • Multiple CD cell marker IVD, control

Cal-Chex - 20844509000246

A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
STRECK, INC.
221101
In Commercial Distribution

  • 20844509000246 ()

  • Total Volume: 3.0 Milliliter
221101

  • Full blood count IVD, calibrator

Para 12 Plus - 20844509000192

A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials of normal level.
STRECK, INC.
218914
In Commercial Distribution

  • 20844509000192 ()

  • Total Volume: 3.0 Milliliter
218914

  • Full blood count IVD, control
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