WATERS TECHNOLOGIES CORPORATION

Address:STAMFORD AVENUE, ALTRINCHAM ROAD,WILMSLOW Manchester,GB

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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

Instrumentation, High Pressure Liquid Chromatography (LDM) (5) Calibrator, Multi-Analyte Mixture (JIX) (2) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Mass Spectrometer, Clinical Use (DOP) (1)

Premarket Exempt

No Yes

Clear

Acquity - 00816776020315 Catalog Number : 725000662IVD

Device Description : Waters 3777C Sample Manager IVD

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : LDM

Prescription Use : No

Device Count : 1

Xevo - 00816776020346 Catalog Number : 186008453IVD

Device Description : Xevo TQ-XS

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : DOP

Prescription Use : No

Device Count : 1

MassTrak - 00816776020421 Catalog Number : 186009311IVD

Device Description : MassTrak™ Endocrine Steroid Calibrator Set

Device Class : 2

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

MassTrak - 00816776020438 Catalog Number : 186009312IVD

Device Description : MassTrak™ Endocrine Steroid Quality Control Set

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Acquity - 00816776020445 Catalog Number : 186015082IVD

Device Description : ACQUITY UPLC I-Class BSM (PLUS) IVD

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : LDM

Prescription Use : No

Device Count : 1

Acquity - 00816776020452 Catalog Number : 186015088IVD

Device Description : ACQUITY UPLC I-Class SM-FTN (PLUS) IVD

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : LDM

Prescription Use : No

Device Count : 1

Acquity - 00816776020469 Catalog Number : 186015087IVD

Device Description : ACQUITY UPLC I-Class SM-FL (PLUS) IVD

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : LDM

Prescription Use : No

Device Count : 1

Acquity - 00816776020476 Catalog Number : 186015014IVD

Device Description : ACQUITY UPLC Sample Organiser IVD

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : LDM

Prescription Use : No

Device Count : 1

MassTrak - 00816776020513 Catalog Number : 186010251IVD

Device Description : MassTrak™ Immunosuppressant Calibrator Set

Device Class : 2

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

MassTrak - 00816776020520 Catalog Number : 186010252IVD

Device Description : MassTrak™ Immunosuppressant Quality Control Set

Device Class : 1

Duns Number: 107186004

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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