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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Affirm 1 Multi Analyt Low Control 12 X 5 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR961-X
In Commercial Distribution

  • 05060500091545 ()
IR961-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 3 X 25 mL + 3 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-WK
In Commercial Distribution

  • 05060500091491 ()
IR460-WK

  • 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
Uric Acid Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR460-R
In Commercial Distribution

  • 05060500091477 ()
IR460-R

  • Uric acid IVD, reagent
UIBC Chromogen Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR152-L
In Commercial Distribution

  • 05060500091460 ()
IR152-L

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Binding Buffer Reagent 6 X 490 mL _ 6 X 10 mL
INFRARED LABORATORY SYSTEMS LLC
IR151-L
In Commercial Distribution

  • 05060500091453 ()
IR151-L

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Reagent 1 X 245 mL + 1 X 5 mL + 1 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-X
In Commercial Distribution

  • 05060500091446 ()
IR150-X

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
UIBC Reagent 3 X 245 mL + 3 X 5 mL + 3 X 80 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-R
In Commercial Distribution

  • 05060500091439 ()
IR150-R

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
Triglycerides Reagent 6 X 500 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR141-L
In Commercial Distribution

  • 05060500091422 ()
IR141-L

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 8 X 50 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-911
In Commercial Distribution

  • 05060500091415 ()
IR140-911

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 1 X 55 mL + 1 powder wedge
INFRARED LABORATORY SYSTEMS LLC
IR140-WK
In Commercial Distribution

  • 05060500091408 ()
IR140-WK

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 2 X 100 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-X
In Commercial Distribution

  • 05060500091392 ()
IR140-X

  • Glucose/ketone/lipid profile IVD, reagent
Triglycerides Reagent 6 X 100 mL (reconstituted)
INFRARED LABORATORY SYSTEMS LLC
IR140-R
In Commercial Distribution

  • 05060500091385 ()
IR140-R

  • Glucose/ketone/lipid profile IVD, reagent
Sodium Reagent 2 X 25 mL + 2 X 12.5 mL
INFRARED LABORATORY SYSTEMS LLC
VI114-WK
In Commercial Distribution

  • 05060500091378 ()
VI114-WK

  • Sodium (Na+) IVD, reagent
Total Protein Biuret Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI133-L
In Commercial Distribution

  • 05060500091361 ()
VI133-L

  • Total protein IVD, reagent
Total Protein Buffer Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI131-L
In Commercial Distribution

  • 05060500091354 ()
VI131-L

  • Total protein IVD, reagent
Total Protein Reagent 4 X 50 mL + 2 X 40 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-911
In Commercial Distribution

  • 05060500091347 ()
VI530-911

  • Total protein IVD, reagent
Total Protein Reagent 3 X 25 mL + 3 X 12.5 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-WK
In Commercial Distribution

  • 05060500091330 ()
VI530-WK

  • Total protein IVD, reagent
Total Protein Reagent 1 X 250 mL + 1 X 125 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-X
In Commercial Distribution

  • 05060500091323 ()
VI530-X

  • Total protein IVD, reagent
Total Protein Reagent 4 X 250 mL + 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-R
In Commercial Distribution

  • 05060500091316 ()
VI530-R

  • Total protein IVD, reagent
Total Protein Single Reagent 6 X 1000 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-L
In Commercial Distribution

  • 05060500091309 ()
VI135-L

  • Total protein IVD, reagent
Total Protein Single Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-X
In Commercial Distribution

  • 05060500091293 ()
VI135-X

  • Total protein IVD, reagent
Total Protein Single Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
VI135-R
In Commercial Distribution

  • 05060500091286 ()
VI135-R

  • Total protein 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 Catalyst Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
IR112-L
In Commercial Distribution

  • 05060500091262 ()
IR112-L

  • Inorganic phosphate (PO43-) 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
Phosphorus Reagent 3 X 250 mL + 3 X 100 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-R
In Commercial Distribution

  • 05060500091217 ()
IR110-R

  • Inorganic phosphate (PO43-) IVD, reagent
Magnesium Reagent 6 x 1000mL
INFRARED LABORATORY SYSTEMS LLC
IR170-L
In Commercial Distribution

  • 05060500091200 ()
IR170-L

  • Magnesium (Mg2+) IVD, reagent
Magnesium Reagent 4 X 20 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-911
In Commercial Distribution

  • 05060500091194 ()
IR170-911

  • Magnesium (Mg2+) IVD, reagent
Magnesium Reagent 2 X 55 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-WK
In Commercial Distribution

  • 05060500091187 ()
IR170-WK

  • Magnesium (Mg2+) IVD, reagent
Magnesium Reagent 2 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-X
In Commercial Distribution

  • 05060500091170 ()
IR170-X

  • Magnesium (Mg2+) IVD, reagent
Magnesium Reagent 6 X 250 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-R
In Commercial Distribution

  • 05060500091163 ()
IR170-R

  • Magnesium (Mg2+) IVD, reagent
LDH Coenzyme Reagent 6 X 500 mL
INFRARED LABORATORY SYSTEMS LLC
UV342-L
In Commercial Distribution

  • 05060500091156 ()
UV342-L

  • Total lactate dehydrogenase (LDH) IVD, reagent
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