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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Creatinine Kinase Substrate 6 X powder vials
INFRARED LABORATORY SYSTEMS LLC
UV312B-L
In Commercial Distribution

  • 05060500090722 ()
UV312B-L

  • Total creatine kinase (CK) IVD, reagent
Creatinine Kinase Substrate Diluent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
UV312A-L
In Commercial Distribution

  • 05060500090715 ()
UV312A-L

  • Total creatine kinase (CK) IVD, reagent
Creatinine Kinase Enzyme/Coenzyme 6 X powder vials
INFRARED LABORATORY SYSTEMS LLC
UV311B-L
In Commercial Distribution

  • 05060500090708 ()
UV311B-L

  • Total creatine kinase (CK) IVD, reagent
Creatinine Kinase Enzyme/Coenzyme Diluent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
UV311A-L
In Commercial Distribution

  • 05060500090692 ()
UV311A-L

  • Total creatine kinase (CK) IVD, reagent
Creatine Kinase Reagent 3 X 25 mL + 3 X 12.5 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
UV310-WK
In Commercial Distribution

  • 05060500090685 ()
UV310-WK

  • Total creatine kinase (CK) IVD, reagent
Creatine Kinase Reagent 1 X 60 mL/1 vial + 1 X 27 mL/1 vial
INFRARED LABORATORY SYSTEMS LLC
UV310-X
In Commercial Distribution

  • 05060500090678 ()
UV310-X

  • Total creatine kinase (CK) IVD, reagent
Creatine Kinase Reagent 3 X 60 mL/3 vials + 3 X 27 mL/3 vials
INFRARED LABORATORY SYSTEMS LLC
UV310-R
In Commercial Distribution

  • 05060500090661 ()
UV310-R

  • Total creatine kinase (CK) IVD, reagent
CO2 Reagent 3 X 50 mL + 3 powder wedges
INFRARED LABORATORY SYSTEMS LLC
UV380-WK
In Commercial Distribution

  • 05060500090654 ()
UV380-WK

  • Carbon dioxide (CO2) IVD, reagent
CO2 Reagent 1 X 250 mL + 1 X powder vial
INFRARED LABORATORY SYSTEMS LLC
UV380-X
In Commercial Distribution

  • 05060500090647 ()
UV380-X

  • Carbon dioxide (CO2) IVD, reagent
CO2 Reagent 3 X 250 mL + 3 powder vials
INFRARED LABORATORY SYSTEMS LLC
UV380-R
In Commercial Distribution

  • 05060500090630 ()
UV380-R

  • Carbon dioxide (CO2) IVD, reagent
Cholesterol Enzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR062-L
In Commercial Distribution

  • 05060500090623 ()
IR062-L

  • Total cholesterol lipid IVD, reagent
Cholesterol Chromogen Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR061-L
In Commercial Distribution

  • 05060500090616 ()
IR061-L

  • Total cholesterol lipid IVD, reagent
Cholesterol Reagent 6 X 50 mL + 3 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-911
In Commercial Distribution

  • 05060500090609 ()
IR060-911

  • Total cholesterol lipid IVD, reagent
Cholesterol Reagent 3 X 25 mL + 3 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-WK
In Commercial Distribution

  • 05060500090593 ()
IR060-WK

  • Total cholesterol lipid IVD, reagent
Cholesterol Reagent 1 X 250 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-X
In Commercial Distribution

  • 05060500090586 ()
IR060-X

  • Total cholesterol lipid IVD, reagent
Cholesterol Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-R
In Commercial Distribution

  • 05060500090579 ()
IR060-R

  • Total cholesterol lipid IVD, reagent
Chloride Reagent 8 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-911
In Commercial Distribution

  • 05060500090562 ()
IR050-911

  • Chloride (Cl-) IVD, reagent
Chloride Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-L
In Commercial Distribution

  • 05060500090555 ()
IR050-L

  • Chloride (Cl-) IVD, reagent
Chloride Reagent 4 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-WK
In Commercial Distribution

  • 05060500090548 ()
IR050-WK

  • Chloride (Cl-) IVD, reagent
Chloride Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-R
Not in Commercial Distribution

  • 05060500090531 ()
IR050-R

  • Chloride (Cl-) IVD, reagent
Chloride Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-X
In Commercial Distribution

  • 05060500090524 ()
IR050-X

  • Chloride (Cl-) IVD, reagent
Chloride Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-R
In Commercial Distribution

  • 05060500090517 ()
IR050-R

  • Chloride (Cl-) IVD, reagent
Calcium Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-L
In Commercial Distribution

  • 05060500090500 ()
IR240-L

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 8 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-911
In Commercial Distribution

  • 05060500090494 ()
IR240-911

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 4 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-WK
In Commercial Distribution

  • 05060500090487 ()
IR240-WK

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-X
In Commercial Distribution

  • 05060500090470 ()
IR240-X

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-R
In Commercial Distribution

  • 05060500090463 ()
IR240-R

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR040-L
In Commercial Distribution

  • 05060500090456 ()
IR040-L

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR040-X
In Commercial Distribution

  • 05060500090449 ()
IR040-X

  • Calcium (Ca2+) IVD, reagent
Calcium Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR040-R
In Commercial Distribution

  • 05060500090432 ()
IR040-R

  • Calcium (Ca2+) IVD, reagent
Total Bilirubin Oxidant Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR452-L
In Commercial Distribution

  • 05060500090425 ()
IR452-L

  • Total bilirubin IVD, reagent
Total Bilirubin R1 Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR451-L
In Commercial Distribution

  • 05060500090418 ()
IR451-L

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 1 X 250 mL + 1 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR450-X
In Commercial Distribution

  • 05060500090401 ()
IR450-X

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 3 X 250 mL + 3 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR450-R
In Commercial Distribution

  • 05060500090395 ()
IR450-R

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-L
In Commercial Distribution

  • 05060500090388 ()
IR700-L

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 8 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-911
In Commercial Distribution

  • 05060500090371 ()
IR700-911

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 4 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-WK
In Commercial Distribution

  • 05060500090364 ()
IR700-WK

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-X
In Commercial Distribution

  • 05060500090357 ()
IR700-X

  • Total bilirubin IVD, reagent
Total Bilirubin Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-R
In Commercial Distribution

  • 05060500090340 ()
IR700-R

  • Total bilirubin IVD, reagent
Direct Bilirubin Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-L
In Commercial Distribution

  • 05060500090333 ()
IR750-L

  • Conjugated (direct) bilirubin IVD, reagent
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