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

Kit, Quality Control For Blood Banking Reagents (KSF) (6) Whole Blood Plasma, Antigen, Antiserum, Control (DGQ) (3) Whole Human Serum, Antigen, Antiserum, Control (DGR) (1)

Premarket Exempt

No Yes

Clear

AccuPlex™ - 00816784020017 Catalog Number : 0505-0001

Device Description : AccuPlex rEbola GP/NP Reference Material 5 x 0.25 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGR

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020024 Catalog Number : 2000-0001

Device Description : ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020031 Catalog Number : 2000-0002

Device Description : ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020048 Catalog Number : 2000-0008

Device Description : ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020055 Catalog Number : 2000-0010

Device Description : ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020062 Catalog Number : 2000-0018

Device Description : ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020123 Catalog Number : 2000-0032

Device Description : ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020130 Catalog Number : 2000-0034

Device Description : ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020147 Catalog Number : 2000-0035

Device Description : ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020154 Catalog Number : 2000-0037

Device Description : ACCURUN 30 EBV IgG 3 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

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