FDA.reportPublic FDA data

NA

Primary DI
05700573075706
Brand
NA
Company
OXOID LIMITED
Model
K610611-2
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700573075706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700573075706057005730757065700573075706

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441256694238oxoid.techsupport@thermofisher.com

Regulatory Flags#

DUNS number
365355452
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384127993REAGENT SPOT INDOLE DMACAMB1448A2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384001774TRYPTONE SOYA BROTHCM0131B2022-12-04

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30014613330158ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330165ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
30014613330196ELVISDIAGNOSTIC HYBRIDS, INC.GQN2019-03-07
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30014613333029ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
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30014613333067ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333074ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
30014613333081ELVISDIAGNOSTIC HYBRIDS, INC.GQN2018-08-07
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04053252589942Light Diagnostics™ Simulfluor® HSV 1/ HSV 2 DFA KitEMD Millipore CorporationGQN2016-09-23