INSTRUMENTATION LABORATORY COMPANY

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

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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

Control, Hematocrit (GLK) (4) Multi-analyte controls, all kinds (assayed) (JJY) (2) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1) System,test,antibodies,b2 - glycoprotein i (b2 - gpi) (MSV) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (1)

Premarket Exempt

No Yes

Clear

ChemSTAT System Evaluator 3 - 08426951293810 Catalog Number : 00044000103

Device Description : ChemSTAT System Evaluator 3, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 10

ChemSTAT Hematocrit Evaluator 1 - 08426951293827 Catalog Number : 00044000104

Device Description : ChemSTAT Hematocrit Evaluator 1, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 10

ChemSTAT Hematocrit Evaluator 2 - 08426951293834 Catalog Number : 00044000105

Device Description : ChemSTAT Hematocrit Evaluator 2, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 10

ChemSTAT Hematocrit Evaluator 3 - 08426951293841 Catalog Number : 00044000106

Device Description : ChemSTAT Hematocrit Evaluator 3, 10 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 10

GEM ChemSTAT critPVP 1-4 - 08426951293858 Catalog Number : 00044001516

Device Description : GEM ChemSTAT critPVP1-4, 4 levels x 4 ampoules x 1.8 mL

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GLK

Prescription Use : Yes

Device Count : 4

GEM Premier ChemSTAT - 08426951293865 Catalog Number : 00044000000

Device Description : GEM Premier ChemSTAT Analyzer

Device Class : 1

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL, JJE

Prescription Use : Yes

Device Count : 1

HemosIL AcuStar Anti-B2GPI Domain 1 - 08426951298778 Catalog Number : 00009800015

Device Description : 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : MSV

Prescription Use : Yes

Device Count : 1

HemosIL AcuStar Anti-B2GPI Domain 1 Controls - 08426951301706 Catalog Number : 00009800022

Device Description : 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tube 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 6

Avox-4 CO-Oximeter Control - L1 - 08426951346448 Catalog Number : 00003310100

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

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 50

Avox-4 CO-Oximeter Control - L2 - 08426951346455 Catalog Number : 00003310200

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

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 50

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