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

ACTIVATED PARTIAL THROMBOPLASTIN (GFO) (2) PLASMA, COAGULATION CONTROL (GGN) (2) SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES (JPA) (2) TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (2) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) TEST, TIME, PARTIAL THROMBOPLASTIN (GGW) (1)

Premarket Exempt

No Yes

Clear

HemosIL D-Dimer Controls - 08426950063179 Catalog Number : 00020008610

Device Description : HemosIL D-Dimer Controls

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 1

HemosIL Free Protein S - 08426950070320 Catalog Number : 00020002700

Device Description : HemosIL Free Protein S

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

HemosIL Normal Control ASSAYED - 08426950071068 Catalog Number : 00020003110

Device Description : HemosIL Normal Control ASSAYED

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 10

HemosIL Rinse Solution (ACL TOP Family) - 08426950075882 Catalog Number : 00020009700

Device Description : HemosIL Rinse Solution (ACL TOP Family) 4000 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JPA

Prescription Use : No

Device Count : 1

Cuvettes (2400 cuvettes) - 08426950075899 Catalog Number : 00029400100

Device Description : Cuvettes (2400 cuvettes)

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : Yes

Device Count : 600

Coatest APC Resistance V-S - 08426950076100 Catalog Number : 82 3138 63

Device Description : Coatest APC Resistance V-S

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGW

Prescription Use : Yes

Device Count : 1

HemosIL SynthASil - 08426950078920 Catalog Number : 00020006800

Device Description : HemosIL SynthASil

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 1

HemosIL APTT-SP - 08426950078937 Catalog Number : 00020006300

Device Description : HemosIL APTT-SP

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 1

HemosIL Wash-R Emulsion - 08426950078944 Catalog Number : 00020002400

Device Description : HemosIL Wash-R Emulsion 1000 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JPA

Prescription Use : Yes

Device Count : 1

HemosIL von Willebrand Factor Activity - 08426950078951 Catalog Number : 00020004700

Device Description : HemosIL von Willebrand Factor Activity

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

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