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

Calibrators, Drug Mixture (DKB) (3) Drug Mixture Control Materials (DIF) (2) Catalytic Methods, Amylase (JFJ) (1) Bromcresol Green Dye-Binding, Albumin (CIX) (1) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

Clear

Synermed® - 05060500091637 Catalog Number : 0853

Device Description : Drugs of Abuse Cutoff Calibrator 1 X 15 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091644 Catalog Number : 0854

Device Description : Drugs of Abuse Intermediate Calibrator 1 X 15 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091651 Catalog Number : 0855

Device Description : Drugs of Abuse High Calibrator 1 X 15 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091668 Catalog Number : 0857

Device Description : Drugs of Abuse Level 1 Control 1 X 15 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091675 Catalog Number : 0858

Device Description : Drugs of Abuse Level 2 Control 1 X 15 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091682 Catalog Number : IR010-1200

Device Description : Albumin Reagent 8 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091699 Catalog Number : VI120-1200

Device Description : AMP Alkaline Phosphatase Reagent 6 X 67mL + 6 powder wedges

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091705 Catalog Number : VI400-1200

Device Description : Amylase Reagent 2 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091712 Catalog Number : UV185-1200

Device Description : ALT Reagent 8 X 67 mL + 2 X 67 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091729 Catalog Number : UV085-1200

Device Description : AST Reagent 8 X 67 mL + 2 X 67 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIT

Prescription Use : Yes

Device Count : 1

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