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) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Validate - 00859110005982 Catalog Number : 701db

Device Description : Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Validate - 00859110005999 Catalog Number : 701sa

Device Class : 1

Duns Number: 075886031

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ACCURUN Anti SARS-COV-2 IgM Controls Kit - 00860006589721 Catalog Number :

Device Description : ACCURUN Anti-SRAS-COV-2 IgM Controls Kit

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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