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

Bromcresol Green Dye-Binding, Albumin (CIX) (5) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (3) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) (JIQ) (1)

Premarket Exempt

Clear

Synermed® - 05060500090005 Catalog Number : IR-500

Device Description : Automated Clinical Chemistry Analyzer IVD

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JIQ

Prescription Use : No

Device Count : 1

Synermed® - 05060500090012 Catalog Number : IR-1200

Device Description : Automated Clinical Chemistry Analyzer IVD

Device Class : 1

Duns Number: 014210494

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Synermed® - 05060500090029 Catalog Number : IR010-R

Device Description : Albumin Reagent 6 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090036 Catalog Number : IR010-X

Device Description : Albumin Reagent 2 X 250 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090043 Catalog Number : IR010-WK

Device Description : Albumin Reagent 4 X 55 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090050 Catalog Number : IR010-911

Device Description : Albumin Reagent 8 X 50 mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090067 Catalog Number : IR010-L

Device Description : Albumin Reagent 6 x 1000mL

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CIX

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090074 Catalog Number : VI120-R

Device Description : AMP Alkaline Phosphatase Reagent 3 X 250 mL + 3 powder vials

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090081 Catalog Number : VI120-X

Device Description : AAMP Alkaline Phosphatase Reagent 1 X 250 mL + 1 powder vial

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Synermed® - 05060500090098 Catalog Number : VI120-WK

Device Description : AMP Alkaline Phosphatase Reagent 3 X 55mL + 3 powder wedges

Device Class : 2

Duns Number: 014210494

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

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