INFRARED LABORATORY SYSTEMS LLC

Address:17408 Tiller Ct Ste 1900,WESTFIELD,IN,46074,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Acid, Uric, Uricase (Colorimetric) (KNK) (1) Biuret (Colorimetric), Total Protein (CEK) (1) Calibrators, Drug Mixture (DKB) (1) Ferrozine (Colorimetric) Iron Binding Capacity (JMO) (1) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1) Ldl & Vldl Precipitation, Hdl (LBR) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) System,Test,Sodium,Enzymatic Method (MZU) (1) Test,System,Potassium,Enzymatic Method (MZV) (1)

Premarket Exempt

Clear

Synermed® - 05060500091934 Catalog Number : IR110-1200

Device Description : Phosphorus Reagent 2 X 67 mL + 1 X 54 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091941 Catalog Number : VI530-1200

Device Description : Total Protein Reagent 6 X 67 mL + 3 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091958 Catalog Number : IR140-1200

Device Description : Triglycerides Reagent 8 X 67 mL + 8 wedges

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091965 Catalog Number : IR150-1200

Device Description : UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JMO

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091972 Catalog Number : IR460-1200

Device Description : Uric Acid Reagent 2 X 67 mL + 1 X 54 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : KNK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091989 Catalog Number : IR056-1200

Device Description : HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091996 Catalog Number : IR059-1200

Device Description : LDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : LBR

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500092009 Catalog Number : VI113-1200

Device Description : Potassium Reagent 2 X 66 mL + 1 X 33 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : MZV

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500092016 Catalog Number : VI114-1200

Device Description : Sodium Reagent 2 X 66 mL + 1 X 66 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : MZU

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500092023 Catalog Number : IR952-DAU

Device Description : Multi-Analyte DAU Calibrator Kit 4 X 15 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : DKB

Prescription Use : Yes

Device Count : 1

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