Lgc Clinical Diagnostics, Inc.

Address:910 Clopper road,Gaithersburg,MD,20878,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

Whole Blood Plasma, Antigen, Antiserum, Control (DGQ) (7) Kit, Quality Control For Blood Banking Reagents (KSF) (2) Kit, Test (Donors), For Bloodborne Pathogen (MYZ) (1)

Premarket Exempt

No Yes

Clear

ACCURUN® - 00816784020161 Catalog Number : 2000-0038

Device Description : ACCURUN 31 EBV IgM 3 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020178 Catalog Number : 2000-0039

Device Description : ACCURUN 40 Series 5000 Anti- Measles, Mumps, Rubella, VZV 3 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020185 Catalog Number : 2000-0040

Device Description : ACCURUN 51 Multi-Marker Hepatitis 1 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020192 Catalog Number : 2000-0041

Device Description : ACCURUN 51 Multi-Marker Hepatitis 1 6 x 3.5 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020208 Catalog Number : 2000-0043

Device Description : ACCURUN 52 Multi-Marker Hepatitis 2 6 x 3.5 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020215 Catalog Number : 2010-0013

Device Description : ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020222 Catalog Number : 2010-0015

Device Description : ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : KSF

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020239 Catalog Number : 2010-0018

Device Description : ACCURUN 800 ToRCH 1 x 1.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020246 Catalog Number : 2010-0020

Device Description : ACCURUN 810 Multi-Marker Negative Contol 6 x 3.5 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020253 Catalog Number : 2015-0065

Device Description : ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : MYZ

Prescription Use : No

Device Count : 1

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