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, Phosphoric-Tungstic (Spectrophotometric), Chloride (CHG) (1) Alkaline Picrate, Colorimetry, Creatinine (CGX) (1) Azo Dye, Calcium (CJY) (1) Bathophenanthroline, Colorimetry, Iron (Non-Heme) (CFM) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Glucose Oxidase, Glucose (CGA) (1) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Photometric Method, Magnesium (JGJ) (1)

Premarket Exempt

Clear

Synermed® - 05060500091835 Catalog Number : IR240-1200

Device Description : Calcium Reagent 8 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091842 Catalog Number : IR050-1200

Device Description : Chloride Reagent 3 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091859 Catalog Number : IR060-1200

Device Description : Cholesterol Reagent 6 X 67 mL + 3 X 54 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091866 Catalog Number : UV310-1200

Device Description : Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091873 Catalog Number : VI560-1200

Device Description : Creatinine Reagent 4 X 67 mL + 4 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091880 Catalog Number : VI410-1200

Device Description : GGT Reagent 3 X 67 mL + 3 wedges

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JQB

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091897 Catalog Number : IR070-1200

Device Description : Glucose Reagent 6 X 67 mL + 3 X 54 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091903 Catalog Number : IR320-1200

Device Description : Serum Iron Reagent 2 X 67 mL + 1 X 44 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFM

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091910 Catalog Number : UV340-1200

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

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091927 Catalog Number : IR170-1200

Device Description : Magnesium Reagent 4 X 67 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

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