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

Catalytic Methods, Amylase (JFJ) (5) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (3) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (2)

Premarket Exempt

Clear

Synermed® - 05060500090104 Catalog Number : VI120-911

Device Description : AMP Alkaline Phosphatase Reagent 4 X 50 mL + 4 powder vials

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090111 Catalog Number : VI121-L

Device Description : AMP Alkaline Phosphatase Reagent 6 X 500 mL + 6 powder vials

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090128 Catalog Number : VI400-R

Device Description : Amylase Reagent 2 X 100 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090135 Catalog Number : VI400-X

Device Description : Amylase Reagent 1 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090142 Catalog Number : VI400-WK

Device Description : Amylase Reagent 3 X 55 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090159 Catalog Number : VI400-911

Device Description : Amylase Reagent 8 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090166 Catalog Number : VI400-R

Device Description : Amylase Reagent 2 X 500 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090173 Catalog Number : UV185-R

Device Description : ALT Reagent 4 X 100 mL + 1 X 100 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090180 Catalog Number : UV185-X

Device Description : ALT Reagent 1 X 100 mL + 1 X 25 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090197 Catalog Number : UV185-WK

Device Description : ALT Reagent 4 X 25 mL + 4 X 6.25 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CKA

Prescription Use : Yes

Device Count : 1

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