Lgc Clinical Diagnostics, Inc.

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

Want to know more about this Organization? Request more information now!

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) (4) Multi-Analyte Controls Unassayed (OHQ) (3) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Kit, Test (Donors), For Bloodborne Pathogen (MYZ) (1)

Premarket Exempt

No Yes

Clear

ACCURUN® - 00816784020260 Catalog Number : 2015-0066

Device Description : ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL

Device Class : 2

Duns Number: 106267123

Premarket Exempt : No

Product Code : MYZ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020277 Catalog Number : 2015-0068

Device Description : ACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020284 Catalog Number : 2015-0070

Device Description : ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020291 Catalog Number : 2015-0071

Device Description : ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020307 Catalog Number : 2015-0072

Device Description : ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020314 Catalog Number : 2015-0073

Device Description : ACCURUN 120 HAV IgG 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : OHQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020321 Catalog Number : 2015-0074

Device Description : ACCURUN 121 HAV IgM 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : OHQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020338 Catalog Number :

Device Description : ACCURUN 121 HAV IgM 6 x 3.5 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : No

Product Code : OHQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020345 Catalog Number : 2015-0077

Device Description : ACCURUN 125 Anti-HBs 1 x 5.0 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

ACCURUN® - 00816784020352 Catalog Number : 2015-0078

Device Description : ACCURUN 125 Anti-HBs 6 x 3.5 mL

Device Class : 1

Duns Number: 106267123

Premarket Exempt : Yes

Product Code : DGQ

Prescription Use : No

Device Count : 1

Previous 1 2 3 4 5 … 23 Next