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

Anti-Factor Xa Activity Test System, Apixaban (QLU) (2) Plasma, Coagulation Control (GGN) (2) SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES (JPA) (2) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) FLAME EMISSION PHOTOMETER FOR CLINICAL USE (JJO) (1) Antithrombin Iii Quantitation (JBQ) (1) Calibrator, Secondary (JIT) (1)

Premarket Exempt

No Yes

Clear

HemosIL Liquid Anti-Xa - 00195226000016 Catalog Number : 00020302602

Device Description : HemosIL Liquid Anti-Xa1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogeni HemosIL Liquid Anti-Xa1. Factor Xa Reagent (0020302612) 5 x 2.5 mL 2. Chromogenic substrate (0020302622) 5 x 3 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : QLU

Prescription Use : Yes

Device Count : 1

HemosIL Apixaban Calibrators - 00195226000023 Catalog Number : 00020015200

Device Description : HemosIL Apixaban Calibrators kit consists of:1. Apixaban Calibrator 1 (002001521 HemosIL Apixaban Calibrators kit consists of:1. Apixaban Calibrator 1 (0020015210): 5 x 1 mL vials2. Apixaban Calibrator 2 (0020015220): 5 x 1 mL vials

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

HemosIL Apixaban Controls - 00195226000030 Catalog Number : 00020015300

Device Description : HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020 HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

HemosIL Liquid Anti-Xa - 00195226000054 Catalog Number : 00020303600

Device Description : HemosIL Liquid Anti-Xa1. Factor Xa Reagent (0020303610) 5 x 5mL2. Chromogenic su HemosIL Liquid Anti-Xa1. Factor Xa Reagent (0020303610) 5 x 5mL2. Chromogenic substrate (0020303620) 5 x 6mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : QLU

Prescription Use : Yes

Device Count : 1

HemosIL Liquid Antithrombin - 00195226000061 Catalog Number : 00020300440

Device Description : HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410)2. 4 x 2 m HemosIL Liquid Antithrombin 1. 4 x 2 mL Factor Xa Reagent (0020300410)2. 4 x 2 mL Chromogenic substrate (0020300420)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 1

HemosIL D-Dimer Controls - 00195226000511 Catalog Number : 00022660030

Device Description : 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL2. Level 2 D-D Contro 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL2. Level 2 D-D Control(Cat. No. 0022660032): 5 vials x 1 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Flame photometer standard 140 Na 5K - 08426950001805 Catalog Number : 00009751750

Device Description : Flame photometer standard 140 Na 5K

Device Class :

Duns Number: 557223252

Premarket Exempt : No

Product Code : JJO

Prescription Use : Yes

Device Count : 50

HemosIL Rinse Solution (ACL Futura Advance) - 08426950003083 Catalog Number : 00020009320

Device Description : HemosIL Rinse Solution (ACL Futura Advance) 2 LIT

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JPA

Prescription Use : No

Device Count : 1

HemosIL Sample Diluent - 08426950003106 Catalog Number : 00009756800

Device Description : HemosIL Sample Diluent 100 mL

Device Class : 2

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : GKP

Prescription Use : Yes

Device Count : 1

Rotors 100 pcs 2000 wells - 08426950003151 Catalog Number : 00006800000

Device Description : Rotors 100 pcs 2000 wells

Device Class :

Duns Number: 557223252

Premarket Exempt : Yes

Product Code : JPA

Prescription Use : Yes

Device Count : 100

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