Lgc Clinical Diagnostics, Inc.

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

Whole Blood Plasma, Antigen, Antiserum, Control (DGQ) (3) Kit, Quality Control For Blood Banking Reagents (KSF) (2) Reagent, Borrelia Serological Reagent (LSR) (2) Antibody Igm,If, Cytomegalovirus Virus (LKQ) (1) Antisera, If, Toxoplasma Gondii (LJK) (1) Kit, Serological, Positive Control (MJX) (1)

Premarket Exempt

No Yes

Clear

ACCURUN® - 00816784020369 Catalog Number : 2015-0079

Device Description : ACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020376 Catalog Number : 2015-0080

Device Description : ACCURUN 130 Borrelia burgdorferi IgG 1 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020383 Catalog Number : 2015-0081

Device Description : ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020390 Catalog Number : 2015-0082

Device Description : ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : LJK

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020406 Catalog Number : 2015-0083

Device Description : ACCURUN 136 Toxoplasma IgM 1 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020413 Catalog Number : 2015-0084

Device Description : ACCURUN 140 Rubella IgG 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : MJX

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020420 Catalog Number : 2015-0086

Device Description : ACCURUN 141 Rubella IgM 1 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020437 Catalog Number : 2015-0087

Device Description : ACCURUN 145 CMV IgG 1 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020444 Catalog Number : 2015-0088

Device Description : ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : LKQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020451 Catalog Number : 2015-0090

Device Description : ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

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