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

Multi-analyte controls, all kinds (assayed) (JJY) (2) Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (DAP) (1)

Premarket Exempt

No Yes

Clear

Avox-4 CO-Oximeter Control - L3 - 08426951346462 Catalog Number : 00003310300

Device Description : Avox-4 CO-Oximeter Control, Level 3

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 50

Avox-4 CO-Oximeter Control - 08426951346479 Catalog Number : 00003310350

Device Description : Avox-4 CO-Oximeter Control Level 1, Level 2 and Level 3

Device Class : 1

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

HemosIL D-Dimer HS 500 - 08426951391615 Catalog Number : 00020500300

Device Description : HemosIL D-Dimer HS 500 (XL)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 1

Kit Rinse Manifold, Packaged - 08430793057080 Catalog Number : 00000011857

Device Description : Bulk ACL TOP System Rinse Manifold

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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