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

Photometric Method, Magnesium (JGJ) (5) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (4) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1)

Premarket Exempt

Clear

Synermed® - 05060500091125 Catalog Number : UV340-WK

Device Description : LDH Reagent 3 X 25 mL + 3 X 10 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091132 Catalog Number : UV340-911

Device Description : LDH Reagent 6 X 50 mL + 3 X 40 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091149 Catalog Number : UV341-L

Device Description : LDH Substrate Reagent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091156 Catalog Number : UV342-L

Device Description : LDH Coenzyme Reagent 6 X 500 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091163 Catalog Number : IR170-R

Device Description : Magnesium Reagent 6 X 250 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091170 Catalog Number : IR170-X

Device Description : Magnesium Reagent 2 X 250 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091187 Catalog Number : IR170-WK

Device Description : Magnesium Reagent 2 X 55 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091194 Catalog Number : IR170-911

Device Description : Magnesium Reagent 4 X 20 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091200 Catalog Number : IR170-L

Device Description : Magnesium Reagent 6 x 1000mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JGJ

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500091217 Catalog Number : IR110-R

Device Description : Phosphorus Reagent 3 X 250 mL + 3 X 100 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CEO

Prescription Use : Yes

Device Count : 1

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