Lgc Clinical Diagnostics, Inc.

Address:221 US Route 1,Cumberland Foreside,ME,04110,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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (8) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2)

Premarket Exempt

No Yes

Clear

Validate - 00859110005586 Catalog Number : 308re

Device Description : Validate Anemia is intended for the quantitative determination of Calibration Ve

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005593 Catalog Number : 401ab

Device Description : Validate CM1 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005609 Catalog Number : 401bc

Device Description : Validate CM1 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005616 Catalog Number : 401db

Device Description : Validate CM1 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005623 Catalog Number : 402ab

Device Description : Validate CM2 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005630 Catalog Number : 402bc

Device Description : Validate CM2 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005647 Catalog Number : 402re

Device Description : Validate CM2 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005654 Catalog Number : 402vt

Device Description : Validate CM2 is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005661 Catalog Number : 403ab

Device Description : Validate PCT is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Validate - 00859110005678 Catalog Number : 403ro

Device Description : Validate PCT is intended for the quantitative determination of Calibration Verif

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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