INSTRUMENTATION LABORATORY COMPANY

Address:180 Hartwell Rd.,Bedford,MA,01730,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

ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (5) ANTITHROMBIN III QUANTITATION (JBQ) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) FLAME EMISSION PHOTOMETER FOR CLINICAL USE (JJO) (1) Multi-analyte controls, all kinds (assayed) (JJY) (1) PLASMA, COAGULATION CONTROL (GGN) (1)

Premarket Exempt

No Yes

Clear

GEM Premier 3000 - BG HCT - 450 Tests - 08426950082538 Catalog Number : 00024345004

Device Description : GEM Premier 3000 3WK - BG HCT - 450 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. - 450 Tests - 08426950082545 Catalog Number : 00024345007

Device Description : GEM Premier 3000 3WK - BG HCT ELECT. - 450 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. GL - 450 Tests - 08426950082552 Catalog Number : 00024345009

Device Description : GEM Premier 3000 3WK - BG HCT ELECT. GL - 450 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. - 600 Tests - 08426950082569 Catalog Number : 00024360007

Device Description : GEM Premier 3000 2WK - BG HCT ELECT. - 600 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. GL - 600 Tests - 08426950082576 Catalog Number : 00024360009

Device Description : GEM Premier 3000 2WK - BG HCT ELECT. GL - 600 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM CVP (Calibration Validation Product) - 08426950082651 Catalog Number : 00024001587

Device Description : GEM CVP (Calibration Validation Product)

Device Class : 1

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Control Plasma LMW Heparin - 08426950083597 Catalog Number : 82 3492 63

Device Description : Control Plasma LMW Heparin

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Flame photometer standard 160 Na 8K - 08426950086796 Catalog Number : 00009751950

Device Description : Flame photometer standard 160 Na 8K

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJO

Prescription Use : Yes

Device Count : 50

HemosIL Liquid AT Substrate - 08426950087571 Catalog Number : 00020002600

Device Description : HemosIL Liquid AT Substrate 6X2 ML

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 6

HemosIL Calibration Plasma - 08426950087595 Catalog Number : 00020003700

Device Description : HemosIL Calibration Plasma

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 10

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