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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Urea Nitrogen (BUN) Reagent 6 X 67 mL + 3 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-1200
In Commercial Distribution

  • 05060500091736 ()
UV190-1200

  • Urea IVD, reagent
AST Reagent 8 X 67 mL + 2 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
UV085-1200
In Commercial Distribution

  • 05060500091729 ()
UV085-1200

  • Total aspartate aminotransferase (AST) IVD, reagent
ALT Reagent 8 X 67 mL + 2 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
UV185-1200
In Commercial Distribution

  • 05060500091712 ()
UV185-1200

  • Alanine aminotransferase (ALT) IVD, reagent
Amylase Reagent 2 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI400-1200
In Commercial Distribution

  • 05060500091705 ()
VI400-1200

  • Total amylase IVD, reagent
AMP Alkaline Phosphatase Reagent 6 X 67mL + 6 powder wedges
INFRARED LABORATORY SYSTEMS LLC
VI120-1200
In Commercial Distribution

  • 05060500091699 ()
VI120-1200

  • Total alkaline phosphatase (ALP) IVD, reagent
Albumin Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR010-1200
In Commercial Distribution

  • 05060500091682 ()
IR010-1200

  • Albumin IVD, reagent
Drugs of Abuse Level 2 Control 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0858
In Commercial Distribution

  • 05060500091675 ()
0858

  • Multiple-type clinical chemistry analyte profile IVD, control
Drugs of Abuse Level 1 Control 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0857
In Commercial Distribution

  • 05060500091668 ()
0857

  • Multiple-type clinical chemistry analyte profile IVD, control
Drugs of Abuse High Calibrator 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0855
In Commercial Distribution

  • 05060500091651 ()
0855

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Drugs of Abuse Intermediate Calibrator 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0854
In Commercial Distribution

  • 05060500091644 ()
0854

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Drugs of Abuse Cutoff Calibrator 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0853
In Commercial Distribution

  • 05060500091637 ()
0853

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Drugs of Abuse Low Calibrator 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
0852
In Commercial Distribution

  • 05060500091620 ()
0852

  • Multiple-type clinical chemistry analyte profile IVD, control
Drugs of Abuse Negative Calibrator 1 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
001
In Commercial Distribution

  • 05060500091613 ()
001

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Alcohol Standards and Controls 6 X 25 mL
INFRARED LABORATORY SYSTEMS LLC
IR952-ETOH
In Commercial Distribution

  • 05060500091606 ()
IR952-ETOH

  • Ethanol (ETOH) IVD, calibrator
ISE Calibrators and Controls 12 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
ISE530-K
In Commercial Distribution

  • 05060500091590 ()
ISE530-K

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
CO2 Controls 12 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
IR960-CO2
In Commercial Distribution

  • 05060500091576 ()
IR960-CO2

  • Carbon dioxide (CO2) IVD, calibrator
CO2 Calibrators 12 X 15 mL
INFRARED LABORATORY SYSTEMS LLC
IR952-CO2
In Commercial Distribution

  • 05060500091569 ()
IR952-CO2

  • Carbon dioxide (CO2) IVD, calibrator
Affirm 2 Multi Analyt High Control 12 X 5 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR962-X
In Commercial Distribution

  • 05060500091552 ()
IR962-X

  • Multiple-type clinical chemistry analyte profile IVD, control
IRCal II Multi Analyt Calibrator 12 X 5 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR954
In Commercial Distribution

  • 05060500091538 ()
IR954

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Uric Acid Enzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR462-L
In Commercial Distribution

  • 05060500091521 ()
IR462-L

  • Uric acid IVD, reagent
Uric Acid Chromogen Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
IR461-L
In Commercial Distribution

  • 05060500091514 ()
IR461-L

  • Uric acid IVD, reagent
Uric Acid Reagent 6 X 50 mL + 3 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-911
In Commercial Distribution

  • 05060500091507 ()
IR460-911

  • Uric acid IVD, reagent
Uric Acid Reagent 1 X 250 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-X
In Commercial Distribution

  • 05060500091484 ()
IR460-X

  • Uric acid IVD, reagent
Potassium Reagent 2 X 25 mL + 2 X 6.25 mL
INFRARED LABORATORY SYSTEMS LLC
VI113-WK
In Commercial Distribution

  • 05060500091279 ()
VI113-WK

  • Potassium (K+) IVD, reagent
Phosphorus Molybdate Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR111-L
In Commercial Distribution

  • 05060500091255 ()
IR111-L

  • Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Reagent 4 X 50 mL + 2 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-911
In Commercial Distribution

  • 05060500091248 ()
IR110-911

  • Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Reagent 3 X 25 mL + 3 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-WK
In Commercial Distribution

  • 05060500091231 ()
IR110-WK

  • Inorganic phosphate (PO43-) IVD, reagent
Phosphorus Reagent 1 X 250 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-X
In Commercial Distribution

  • 05060500091224 ()
IR110-X

  • Inorganic phosphate (PO43-) 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 ISE Diluent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
ISE720
In Commercial Distribution

  • 05060500091057 ()
ISE720

  • 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 Reagent 1 X 250 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-X
In Commercial Distribution

  • 05060500090999 ()
IR320-X

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

  • 05060500090968 ()
IR071-L

  • Glucose 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
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