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, TIME, PARTIAL THROMBOPLASTIN (GGW) (3) ANTITHROMBIN III QUANTITATION (JBQ) (2) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) TEST, THROMBIN TIME (GJA) (1) TEST, TIME, PROTHROMBIN (GJS) (1) Multi-analyte controls, all kinds (assayed) (JJY) (1) FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL (DAP) (1)

Premarket Exempt

No Yes

Clear

HemosIL Liquid Antithrombin - 08426950056003 Catalog Number : 00020002500

Device Description : HemosIL Liquid Antithrombin

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 1

HemosIL Thrombin Time - 08426950058366 Catalog Number : 00009758515

Device Description : HemosIL Thrombin Time

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GJA

Prescription Use : Yes

Device Count : 1

HemosIL PT-Fibrinogen HS PLUS - 08426950058403 Catalog Number : 00008469810

Device Description : HemosIL PT-Fibrinogen HS PLUS

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 5

Coatest APC Resistance V - 08426950060017 Catalog Number : 82 3120 63

Device Description : Coatest APC Resistance V

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGW

Prescription Use : Yes

Device Count : 1

Coatest APC Resistance - 08426950060147 Catalog Number : 82 2643 63

Device Description : Coatest APC Resistance

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGW

Prescription Use : Yes

Device Count : 1

HemosIL D-Dimer - 08426950060451 Catalog Number : 00020008500

Device Description : HemosIL D-Dimer

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 1

ContrIL 7 Multipak - 08426950061687 Catalog Number : 00024001380

Device Description : ContrIL 7 Multipak

Device Class : 1

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

HemosIL Factor Diluent - 08426950062295 Catalog Number : 00009757600

Device Description : HemosIL Factor Diluent 100 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : Yes

Device Count : 1

HemosIL Antithrombin - 08426950062325 Catalog Number : 00020008900

Device Description : HemosIL Antithrombin

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 1

HemosIL Factor V Leiden (APC Resistance V) - 08426950062424 Catalog Number : 00020008700

Device Description : HemosIL Factor V Leiden (APC Resistance V)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGW

Prescription Use : Yes

Device Count : 1

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