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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Triglycerides Reagent 8 X 67 mL + 8 wedges
INFRARED LABORATORY SYSTEMS LLC
IR140-1200
In Commercial Distribution

  • 05060500091958 ()
IR140-1200

  • Glucose/ketone/lipid profile IVD, reagent
Total Protein Reagent 6 X 67 mL + 3 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-1200
In Commercial Distribution

  • 05060500091941 ()
VI530-1200

  • Total protein IVD, reagent
Phosphorus Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-1200
In Commercial Distribution

  • 05060500091934 ()
IR110-1200

  • Inorganic phosphate (PO43-) IVD, reagent
Magnesium Reagent 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-1200
In Commercial Distribution

  • 05060500091927 ()
IR170-1200

  • Magnesium (Mg2+) IVD, reagent
LDH Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-1200
In Commercial Distribution

  • 05060500091910 ()
UV340-1200

  • Total lactate dehydrogenase (LDH) IVD, reagent
Serum Iron Reagent 2 X 67 mL + 1 X 44 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-1200
In Commercial Distribution

  • 05060500091903 ()
IR320-1200

  • Iron IVD, reagent
Glucose Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-1200
In Commercial Distribution

  • 05060500091897 ()
IR070-1200

  • Glucose IVD, reagent
GGT Reagent 3 X 67 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
VI410-1200
In Commercial Distribution

  • 05060500091880 ()
VI410-1200

  • Gamma-glutamyltransferase (GGT) IVD, reagent
Creatinine Reagent 4 X 67 mL + 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-1200
In Commercial Distribution

  • 05060500091873 ()
VI560-1200

  • Creatinine IVD, reagent
Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
UV310-1200
In Commercial Distribution

  • 05060500091866 ()
UV310-1200

  • Total creatine kinase (CK) IVD, reagent
Cholesterol Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-1200
In Commercial Distribution

  • 05060500091859 ()
IR060-1200

  • Total cholesterol lipid IVD, reagent
Chloride Reagent 3 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR050-1200
In Commercial Distribution

  • 05060500091842 ()
IR050-1200

  • Chloride (Cl-) IVD, reagent
Calcium Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-1200
In Commercial Distribution

  • 05060500091835 ()
IR240-1200

  • Calcium (Ca2+) IVD, reagent
Total Bilirubin Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR700-1200
In Commercial Distribution

  • 05060500091828 ()
IR700-1200

  • Total bilirubin IVD, reagent
Direct Bilirubin Reagent 2 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR750-1200
In Commercial Distribution

  • 05060500091811 ()
IR750-1200

  • Conjugated (direct) bilirubin IVD, reagent
Urea Nitrogen (BUN) Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV193-L
In Commercial Distribution

  • 05060500091804 ()
UV193-L

  • Urea IVD, reagent
Urea Nitrogen (BUN) Enzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV192-L
In Commercial Distribution

  • 05060500091798 ()
UV192-L

  • Urea IVD, reagent
Urea Nitrogen (BUN) Coenzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV191-L
In Commercial Distribution

  • 05060500091781 ()
UV191-L

  • Urea IVD, reagent
Urea Nitrogen (BUN) Reagent 6 X 50 mL + 3 X 50 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-911
In Commercial Distribution

  • 05060500091774 ()
UV190-911

  • Urea IVD, reagent
Urea Nitrogen (BUN) Reagent 4 X 25 mL + 4 X 12.5 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-WK
In Commercial Distribution

  • 05060500091767 ()
UV190-WK

  • Urea IVD, reagent
Urea Nitrogen (BUN) Reagent 1 X 200 mL + 1 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-X
In Commercial Distribution

  • 05060500091750 ()
UV190-X

  • Urea IVD, reagent
Urea Nitrogen (BUN) Reagent 3 X 200 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
UV190-R
In Commercial Distribution

  • 05060500091743 ()
UV190-R

  • Urea IVD, reagent
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
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