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) (7) PLASMA, COAGULATION CONTROL (GGN) (2) TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (1)

Premarket Exempt

No Yes

Clear

HemosIL Plasminogen - 08426950078975 Catalog Number : 00020009000

Device Description : HemosIL Plasminogen

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

HemosIL Low Abnormal Control ASSAYED - 08426950078982 Catalog Number : 00020003210

Device Description : HemosIL Low Abnormal Control ASSAYED

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 10

HemosIL High Abnormal Control ASSAYED - 08426950078999 Catalog Number : 00020003310

Device Description : HemosIL High Abnormal Control ASSAYED

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 10

GEM Premier 3000 iQM - BG HCT - 150 Tests - 08426950082361 Catalog Number : 00024315084

Device Description : GEM Premier 3000 iQM 3WK - BG HCT - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. - 150 Tests - 08426950082378 Catalog Number : 00024315087

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. GL - 150 Tests - 08426950082385 Catalog Number : 00024315089

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. GL - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT - 300 Tests - 08426950082392 Catalog Number : 00024330084

Device Description : GEM Premier 3000 iQM 3WK - BG HCT - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. - 300 Tests - 08426950082408 Catalog Number : 00024330087

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. GL - 300 Tests - 08426950082415 Catalog Number : 00024330089

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. GL - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT - 450 Tests - 08426950082422 Catalog Number : 00024345084

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

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

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