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

Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride (CHG) (6) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (3) Azo Dye, Calcium (CJY) (1)

Premarket Exempt

Clear

Synermed® - 05060500090500 Catalog Number : IR240-L

Device Description : Calcium Reagent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090517 Catalog Number : IR050-R

Device Description : Chloride Reagent 6 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090524 Catalog Number : IR050-X

Device Description : Chloride Reagent 2 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090531 Catalog Number : IR050-R

Device Description : Chloride Reagent 6 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090548 Catalog Number : IR050-WK

Device Description : Chloride Reagent 4 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090555 Catalog Number : IR050-L

Device Description : Chloride Reagent 6 X 1000 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090562 Catalog Number : IR050-911

Device Description : Chloride Reagent 8 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHG

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090579 Catalog Number : IR060-R

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

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090586 Catalog Number : IR060-X

Device Description : Cholesterol Reagent 1 X 250 mL + 1 X 100 mL

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090593 Catalog Number : IR060-WK

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

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : CHH

Prescription Use : Yes

Device Count : 1

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