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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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Simplexa™ Flu A/B & RSV - 20816101025538

No Description
DIASORIN MOLECULAR LLC
MOL2600
In Commercial Distribution

  • 20816101025538 ()
MOL2600

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

No Description
DIASORIN MOLECULAR LLC
MOL2500
Not in Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ HSV 1 & 2 Positive Control Pack - 20816101025514

No Description
DIASORIN MOLECULAR LLC
MOL2160
In Commercial Distribution

  • 20816101025514 ()
MOL2160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Simplexa™ HSV 1 & 2 Direct - 20816101025507

No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Spectral Calibration Panel - 20816101025101

No Description
DIASORIN MOLECULAR LLC
SC1100
In Commercial Distribution

  • 20816101025101 ()
SC1100

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

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
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