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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LDH Substrate Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
UV341-L
In Commercial Distribution

  • 05060500091149 ()
UV341-L

  • Total lactate dehydrogenase (LDH) IVD, reagent
LDH Reagent 6 X 50 mL + 3 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-911
In Commercial Distribution

  • 05060500091132 ()
UV340-911

  • Total lactate dehydrogenase (LDH) IVD, reagent
LDH Reagent 3 X 25 mL + 3 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-WK
In Commercial Distribution

  • 05060500091125 ()
UV340-WK

  • Total lactate dehydrogenase (LDH) IVD, reagent
LDH Reagent 1 X 250 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-X
In Commercial Distribution

  • 05060500091118 ()
UV340-X

  • Total lactate dehydrogenase (LDH) IVD, reagent
LDH Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-R
In Commercial Distribution

  • 05060500091101 ()
UV340-R

  • Total lactate dehydrogenase (LDH) IVD, reagent
Olympus KCL 1 M Solution 6 x 500mL
INFRARED LABORATORY SYSTEMS LLC
ISE820
In Commercial Distribution

  • 05060500091095 ()
ISE820

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Olympus ISE Mid Standard 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
ISE810
In Commercial Distribution

  • 05060500091088 ()
ISE810

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Olympus ISE Buffer 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
ISE800
In Commercial Distribution

  • 05060500091071 ()
ISE800

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Hitachi KCL 1 M Solution 6 x 500mL
INFRARED LABORATORY SYSTEMS LLC
ISE730
In Commercial Distribution

  • 05060500091064 ()
ISE730

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Hitachi ISE Diluent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
ISE720
In Commercial Distribution

  • 05060500091057 ()
ISE720

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Hitachi ISE Internal Reference 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
ISE710
In Commercial Distribution

  • 05060500091040 ()
ISE710

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Serum Iron Chromogen Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR322-L
In Commercial Distribution

  • 05060500091033 ()
IR322-L

  • Iron IVD, reagent
Serum Iron Buffer Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR321-L
In Commercial Distribution

  • 05060500091026 ()
IR321-L

  • Iron IVD, reagent
Serum Iron Reagent 4 X 50 mL + 2 X 29 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-911
In Commercial Distribution

  • 05060500091019 ()
IR320-911

  • Iron IVD, reagent
Serum Iron Reagent 3 X 25 mL + 3 X 7.2 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-WK
In Commercial Distribution

  • 05060500091002 ()
IR320-WK

  • Iron IVD, reagent
Serum Iron Reagent 1 X 250 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-X
In Commercial Distribution

  • 05060500090999 ()
IR320-X

  • Iron IVD, reagent
Serum Iron Reagent 3 X 250 mL + 3 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-R
In Commercial Distribution

  • 05060500090982 ()
IR320-R

  • Iron IVD, reagent
Glucose Enzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR072-L
In Commercial Distribution

  • 05060500090975 ()
IR072-L

  • Glucose IVD, reagent
Glucose Chromogen Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR071-L
In Commercial Distribution

  • 05060500090968 ()
IR071-L

  • Glucose IVD, reagent
Glucose Reagent 6 X 50 mL + 3 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-911
In Commercial Distribution

  • 05060500090951 ()
IR070-911

  • Glucose IVD, reagent
Glucose Reagent 4 X 25 mL + 4 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-WK
In Commercial Distribution

  • 05060500090944 ()
IR070-WK

  • Glucose IVD, reagent
Glucose Reagent 1 X 250 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-X
In Commercial Distribution

  • 05060500090937 ()
IR070-X

  • Glucose IVD, reagent
Glucose Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-R
In Commercial Distribution

  • 05060500090920 ()
IR070-R

  • Glucose IVD, reagent
GGT Reagent 6 X 500 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
VI411-L
In Commercial Distribution

  • 05060500090913 ()
VI411-L

  • Gamma-glutamyltransferase (GGT) IVD, reagent
GGT Reagent 8 X 50 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
VI410-911
In Commercial Distribution

  • 05060500090906 ()
VI410-911

  • Gamma-glutamyltransferase (GGT) IVD, reagent
GGT Reagent 3 X 55 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
VI410-WK
In Commercial Distribution

  • 05060500090890 ()
VI410-WK

  • Gamma-glutamyltransferase (GGT) IVD, reagent
GGT Reagent 2 X 50 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
VI410-X
In Commercial Distribution

  • 05060500090883 ()
VI410-X

  • Gamma-glutamyltransferase (GGT) IVD, reagent
GGT Reagent 6 X 100 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
VI410-R
In Commercial Distribution

  • 05060500090876 ()
VI410-R

  • Gamma-glutamyltransferase (GGT) IVD, reagent
LDL-Cholesterol Reagent 1 X 25 mL + 1 X 8.4 mL
INFRARED LABORATORY SYSTEMS LLC
IR059-WK
In Commercial Distribution

  • 05060500090869 ()
IR059-WK

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
LDL-Cholesterol Reagent 1 X 60 mL + 1 X 20 mL
INFRARED LABORATORY SYSTEMS LLC
IR059-X
In Commercial Distribution

  • 05060500090852 ()
IR059-X

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
LDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR059-R
In Commercial Distribution

  • 05060500090845 ()
IR059-R

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
HDL-Cholesterol Reagent 1 X 25 mL + 1 X 8.4 mL
INFRARED LABORATORY SYSTEMS LLC
IR056-WK
In Commercial Distribution

  • 05060500090838 ()
IR056-WK

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
HDL-Cholesterol Reagent 1 X 60 mL + 1 X 20 mL
INFRARED LABORATORY SYSTEMS LLC
IR056-X
In Commercial Distribution

  • 05060500090821 ()
IR056-X

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
HDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR056-R
In Commercial Distribution

  • 05060500090814 ()
IR056-R

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
Creatinine Picrate Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
VI562-L
In Commercial Distribution

  • 05060500090784 ()
VI562-L

  • Creatinine IVD, reagent
Creatinine Decolorizing Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
VI561-L
In Commercial Distribution

  • 05060500090777 ()
VI561-L

  • Creatinine IVD, reagent
Creatinine Reagent 4 X 50 mL + 4 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-911
In Commercial Distribution

  • 05060500090760 ()
VI560-911

  • Creatinine IVD, reagent
Creatinine Reagent 3 X 25 mL + 3 X 25 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-WK
In Commercial Distribution

  • 05060500090753 ()
VI560-WK

  • Creatinine IVD, reagent
Creatinine Reagent 1 X 250 mL + 1 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI5600-X
In Commercial Distribution

  • 05060500090746 ()
VI5600-X

  • Creatinine IVD, reagent
Creatinine Reagent 3 X 250 mL + 3 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-R
In Commercial Distribution

  • 05060500090739 ()
VI560-R

  • Creatinine IVD, reagent
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
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