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

Biuret (Colorimetric), Total Protein (CEK) (5) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (4) System,Test,Sodium,Enzymatic Method (MZU) (1)

Premarket Exempt

Clear

Synermed® - 05060500091323 Catalog Number : VI530-X

Device Description : Total Protein Reagent 1 X 250 mL + 1 X 125 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091330 Catalog Number : VI530-WK

Device Description : Total Protein Reagent 3 X 25 mL + 3 X 12.5 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091347 Catalog Number : VI530-911

Device Description : Total Protein Reagent 4 X 50 mL + 2 X 40 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091354 Catalog Number : VI131-L

Device Description : Total Protein Buffer Reagent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091361 Catalog Number : VI133-L

Device Description : Total Protein Biuret Reagent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091378 Catalog Number : VI114-WK

Device Description : Sodium Reagent 2 X 25 mL + 2 X 12.5 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : MZU

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091385 Catalog Number : IR140-R

Device Description : Triglycerides Reagent 6 X 100 mL (reconstituted)

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091392 Catalog Number : IR140-X

Device Description : Triglycerides Reagent 2 X 100 mL (reconstituted)

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091408 Catalog Number : IR140-WK

Device Description : Triglycerides Reagent 1 X 55 mL + 1 powder wedge

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091415 Catalog Number : IR140-911

Device Description : Triglycerides Reagent 8 X 50 mL (reconstituted)

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CDT

Prescription Use : Yes

Device Count : 1

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