INSTRUMENTATION LABORATORY COMPANY

Address:526 Route 303,ORANGEBURG,NY,10962,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

TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (3) CONTROL, HEMATOCRIT (GLK) (2) ASSAY, HEPARIN (KFF) (1) FLAME EMISSION PHOTOMETER FOR CLINICAL USE (JJO) (1) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) (JJS) (1) CALIBRATOR, PRIMARY (JIS) (1)

Premarket Exempt

No Yes

Clear

ContrIL Spectrum Control, Level 3 - 08426950029175 Catalog Number : 00009833850

Device Description : ContrIL Spectrum Control, Level 3

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJS

Prescription Use : No

Device Count : 50

HemosIL Plasmin Inhibitor - 08426950031734 Catalog Number : 00020009200

Device Description : HemosIL Plasmin Inhibitor

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Flame photometer standard 140 Na 5K 1Li - 08426950037095 Catalog Number : 00003331350

Device Description : Flame photometer standard 140 Na 5K 1Li

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJO

Prescription Use : Yes

Device Count : 50

HemosIL von Willebrand Factor Antigen - 08426950041177 Catalog Number : 00020002300

Device Description : HemosIL von Willebrand Factor Antigen

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

HemosIL Heparin - 08426950042211 Catalog Number : 00020009400

Device Description : HemosIL Heparin

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : KFF

Prescription Use : Yes

Device Count : 1

HemosIL ProClot Diluent - 08426950043966 Catalog Number : 00008468600

Device Description : HemosIL ProClot Diluent 100 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Hct Check - Low Level - 08426950046653 Catalog Number : 00009832350

Device Description : Hct Check - Low Level

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GLK

Prescription Use : No

Device Count : 50

Hct Check - High Level - 08426950046660 Catalog Number : 00009832450

Device Description : Hct Check - High Level

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GLK

Prescription Use : No

Device Count : 50

Hct Calibrator - 08426950046677 Catalog Number : 00009832550

Device Description : HCT CALIBRATOR 14 1600 SYNTH 50X2ML

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JIS

Prescription Use : No

Device Count : 50

HemosIL Cleaning Solution (Clean A) - 08426950055990 Catalog Number : 00009831700

Device Description : HemosIL Cleaning Solution (Clean A) 500 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : Yes

Device Count : 1

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