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

Alkaline Picrate, Colorimetry, Creatinine (CGX) (6) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (3) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1)

Premarket Exempt

Clear

Synermed® - 05060500090708 Catalog Number : UV311B-L

Device Description : Creatinine Kinase Enzyme/Coenzyme 6 X powder vials

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090715 Catalog Number : UV312A-L

Device Description : Creatinine Kinase Substrate Diluent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090722 Catalog Number : UV312B-L

Device Description : Creatinine Kinase Substrate 6 X powder vials

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090739 Catalog Number : VI560-R

Device Description : Creatinine Reagent 3 X 250 mL + 3 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090746 Catalog Number : VI5600-X

Device Description : Creatinine Reagent 1 X 250 mL + 1 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090753 Catalog Number : VI560-WK

Device Description : Creatinine Reagent 3 X 25 mL + 3 X 25 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090760 Catalog Number : VI560-911

Device Description : Creatinine Reagent 4 X 50 mL + 4 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090777 Catalog Number : VI561-L

Device Description : Creatinine Decolorizing Reagent 6 X 500 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090784 Catalog Number : VI562-L

Device Description : Creatinine Picrate Reagent 6 X 500 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CGX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090814 Catalog Number : IR056-R

Device Description : HDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : LBS

Prescription Use : Yes

Device Count : 1

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